{"product_id":"cold-chain-controlled-temperature-gmp-gdp-guide","title":"Operational Guide to Cold Chain \u0026 Controlled Temperature Systems in GMP\/GDP (First Edition + Toolkit)","description":"\u003cdiv style=\"font-family:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;color:#17354F;line-height:1.65\"\u003e\n\u003cdiv style=\"background:#102D4F;border-radius:14px;padding:34px 30px 30px 30px;color:#ffffff;margin-bottom:26px\"\u003e\n\u003cdiv style=\"display:inline-block;background:#BCD4E4;color:#102D4F;font-size:12px;font-weight:700;letter-spacing:1.6px;text-transform:uppercase;padding:6px 12px;border-radius:4px;margin-bottom:16px\"\u003eFirst edition · v1.0 · regulatory verification 28\/09\/2026\u003c\/div\u003e\n\u003ch3 style=\"margin:0 0 12px 0;font-size:28px;line-height:1.25;color:#ffffff;font-weight:800\"\u003eFrom the product's authorised condition to a system under control: cold rooms, refrigerators, freezers, ULTs and shipments specified, qualified, mapped and monitored, with the source next to every value.\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 20px 0;font-size:16px;color:#DDEBF3;max-width:700px\"\u003eAn engineering and quality guide for the people who design, qualify and run the temperature-controlled systems of a pharmaceutical company: requirements and temperature strategy, storage, transport, monitoring and alarms, qualification and temperature mapping, lifecycle and procurement. \u003cstrong\u003e24 chapters in six parts\u003c\/strong\u003e and 6 appendices, 273 pages in the Italian edition and 275 in the English one, and 24 editable tools in Word and Excel, for €199.\u003c\/p\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:9px\"\u003e\n\u003cspan style=\"background:#163F68;color:#DDEBF3;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e273 pages (ITA) · 275 (ENG) · PDF A4\u003c\/span\u003e\u003cspan style=\"background:#163F68;color:#DDEBF3;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e24 chapters in six parts + 6 appendices\u003c\/span\u003e\u003cspan style=\"background:#163F68;color:#DDEBF3;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e24 tools: 12 Word + 12 Excel\u003c\/span\u003e\u003cspan style=\"background:#163F68;color:#DDEBF3;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e89 sources in the register\u003c\/span\u003e\u003cspan style=\"background:#163F68;color:#DDEBF3;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e113 tracked decisions\u003c\/span\u003e\u003cspan style=\"background:#163F68;color:#DDEBF3;font-size:13px;padding:7px 13px;border-radius:20px\"\u003eDigital product: download after payment\u003c\/span\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"background:#F4FAFC;border:1px solid #D6E7ED;border-left:4px solid #075E99;border-radius:0 11px 11px 0;padding:16px 20px;margin-bottom:26px;font-size:14.5px;color:#17354F\"\u003e\u003cstrong style=\"color:#075E99\"\u003eOne language per purchase: the variant decides.\u003c\/strong\u003e The \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e variant gives you the PDF guide and the 24 tools in Italian; the \u003cstrong\u003eENG - English\u003c\/strong\u003e variant gives them in English. Both editions have the same structure, the same tools and the same codes. No files exist in French, German or Spanish.\u003c\/div\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 8px 0;color:#102D4F\"\u003eThe problems it addresses\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 14px 0;font-size:15px;color:#536F84;max-width:720px\"\u003eThe mistakes the guide takes apart, each measured against a text, with its status and its force in the market where it applies.\u003c\/p\u003e\n\u003cdiv style=\"font-size:15px;color:#17354F;margin-bottom:26px\"\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eValues \"required by law\" that no regulation sets.\u003c\/strong\u003e Mapping duration, number of sensors, requalification frequency, alarm delays, permitted excursions: no regulation gives a universal value. The guide reports the values the sources write, with their nature (requirement, recommendation, example, test criterion), and leaves the others \u0026lt;to be defined\u0026gt; with the decision code.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003e\"Standard\" alarm delays.\u003c\/strong\u003e Thresholds and delays are derived from measured transients and from the time available for the response: a delay longer than the available response time is a design flaw. Chapter 15 and tool CC-TK-15 calculate the time budget of each threshold.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003e\"The carrier is certified, so the lane is qualified.\"\u003c\/strong\u003e CEIV Pharma certifies the logistics node, not the container or the lane: packaging and lane qualification is demonstrated by testing (Chapters 10-12).\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eAlarm, excursion and decision mixed up.\u003c\/strong\u003e An alarm is a system signal, an excursion is an exposure outside the prescribed range, the product decision is a documented quality assessment. A period without data does not demonstrate the absence of excursions, and freezing is never averaged.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eWho verifies transport.\u003c\/strong\u003e Transport from manufacturing sites is verified under EU GMP Annex 15, §6; wholesale distribution operations follow Chapter 9 of the EU GDP. Chapter 1 allocates roles, contracts and quality agreements.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eSuppliers chosen on price.\u003c\/strong\u003e Binding requirements kept apart from scores, quality and service responsibilities written into the agreements, CAPEX and OPEX over the same horizon: Chapters 23 and 24 with CC-TK-23 and CC-TK-24.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:14px;margin-bottom:26px\"\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F4FAFC;border:1px solid #D6E7ED;border-top:3px solid #075E99;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#075E99;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThe guide\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#17354F\"\u003e24 chapters in six parts, named after the six areas of the Cold Chain hub, and 6 appendices. Chapters 2-23 follow the same fourteen sections, from the problem and the decision to the evidence: \u003cstrong\u003eproduct and authorised condition → real system → risk → text, status and force → value with its nature → company decision → test → record → evidence\u003c\/strong\u003e.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#F4FAFC;border:1px solid #D6E7ED;border-top:3px solid #075E99;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#075E99;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThe toolkit\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#17354F\"\u003e24 editable tools: 12 Word templates and 12 Excel workbooks, each as a clean template and as a filled-in example. The workbooks have a Read_Me, formulas written out in plain text, error checks and a \"Check\" sheet that recalculates the book's examples; they return only \"Comparison with the entered criteria\" or \"Quality assessment required\".\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#F4FAFC;border:1px solid #D6E7ED;border-top:3px solid #075E99;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#075E99;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eFour integrated cases\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#17354F\"\u003eA cold room, a passive shipment, an excursion and a ULT failure, at the fictitious company Arvena Pharma, linked to the tools with the same identifiers. Chapter 24 closes with 40 questions an inspector may ask, each with the expected evidence.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"background:#F4FAFC;border-left:4px solid #075E99;border-radius:0 11px 11px 0;padding:22px 24px;margin-bottom:30px\"\u003e\n\u003cdiv style=\"font-size:19px;font-weight:800;color:#075E99;margin-bottom:10px\"\u003e€199, revision v1.0 with regulatory verification as of 28\/09\/2026\u003c\/div\u003e\n\u003cp style=\"margin:0 0 11px 0;font-size:15px;color:#17354F\"\u003eThe status of every source is verified as of \u003cstrong\u003e28\/09\/2026\u003c\/strong\u003e. The source register holds \u003cstrong\u003e89 entries\u003c\/strong\u003e, and the \u003cstrong\u003e113 decisions\u003c\/strong\u003e the guide leaves to the company are tracked with who decides, on what basis and where it is recorded.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0;font-size:15px;color:#17354F\"\u003eThe price is \u003cstrong\u003e€199.00\u003c\/strong\u003e per variant (guide + toolkit in the chosen language). First edition, September 2026, revision v1.0: 273 pages in the Italian edition, 275 in the English one. The revision on sale is stated on this page, together with the date of the regulatory verification. When the texts change, you receive the revised guide and toolkit at no extra cost.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#102D4F\"\u003eThe 24 tools, in six groups\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 18px 0;font-size:15px;color:#536F84;max-width:720px\"\u003eOne folder per part of the book, with the exact file titles of the English edition. \u003cstrong\u003eNo operational value is preloaded\u003c\/strong\u003e: operating conditions, thresholds and delays, number and position of sensors, mapping duration, acceptance criteria, calibration and requalification intervals stay \u0026lt;to be defined\u0026gt;, with the decision code.\u003c\/p\u003e\n\u003cdiv style=\"font-size:13px;font-weight:700;color:#075E99;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e01_Requirements · Requirements \u0026amp; Temperature Strategy\u003c\/div\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\n\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-01 · Cold Chain Project Brief \u0026amp; Responsibility Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003ePurpose, products, systems, stakeholders, boundaries and responsibilities of the programme.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-02 · Cold Chain \u0026amp; Controlled Temperature URS\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eVerifiable requirements, criticality, verification method and expected evidence.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-03 · Product Temperature \u0026amp; Stability Register\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eAuthorised conditions with their source, sensitivity, available stability information, gaps and approvals.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-04 · Cold Chain Risk Assessment\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eRisks, causes, effects, controls, evidence, residual risk and actions: a score alone is no justification.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"font-size:13px;font-weight:700;color:#075E99;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e02_Storage · Storage Systems \u0026amp; Equipment\u003c\/div\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\n\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-05 · Storage Technology Selection Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eCold rooms, refrigerators, freezers and ULTs compared, with mandatory requirements kept apart from weighted criteria.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-06 · Storage Design Review Checklist\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eAirflow, racking, loads, doors, environment, installation and service.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-07 · Load Pattern \u0026amp; Recovery Challenge Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eConfigurations, scenarios, justified tests and results.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-08 · Cold Chain Contingency Plan\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003ePower failures, breakdowns, transfers, alternative capacity, responsibilities and a practical test of the plan.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"font-size:13px;font-weight:700;color:#075E99;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e03_Transport · Transport \u0026amp; Distribution\u003c\/div\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\n\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-09 · Transport Lane Risk Assessment\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eLanes, times, seasons, handovers, stops, customs and critical points.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-10 · Thermal Packaging Qualification Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eConfiguration, payload, pack-out, refrigerants, test profiles, criteria and report.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-11 · Transport \u0026amp; Lane Qualification Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eActive and passive systems, lanes, conditions, tests, monitoring, deviations and conclusions.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-12 · Shipment Monitoring \u0026amp; Chain-of-Custody Log\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eProduct and batch, configuration, loggers, handovers, times, receipt and linked evidence.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"font-size:13px;font-weight:700;color:#075E99;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e04_Monitoring · Monitoring \u0026amp; Alarm Management\u003c\/div\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\n\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-13 · Sensor \u0026amp; Calibration Register\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eIdentifier, position, range, calibration, uncertainty, status, due dates and intermediate checks.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-14 · Monitoring System \u0026amp; Data Lifecycle Specification\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eAcquisition, integrity, access, timestamps, connectivity, backup, restore and retention.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-15 · Alarm Rationalisation \u0026amp; Escalation Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eCondition, justified threshold, delay, response, escalation, coverage, tests and time budget.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-16 · Alarm \u0026amp; Failure Challenge Test Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eAlarms, sensor failure, power failure, network, buffering, notifications and restoration.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"font-size:13px;font-weight:700;color:#075E99;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e05_Qualification · Qualification \u0026amp; Temperature Mapping\u003c\/div\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\n\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-17 · Qualification Plan \u0026amp; IQ\/OQ\/PQ Protocol Framework\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003ePlan, responsibilities, prerequisites, verifications and release, with the DQ, FAT and SAT interfaces.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-18 · Temperature Mapping Protocol \u0026amp; Report\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eObjectives, sensor layout, loads, conditions, acquisition, deviations, analysis and conclusions.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-19 · Temperature Mapping Data Analysis\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eRaw data kept, timestamps and gaps checked, results per sensor, trends and excursions against the entered criteria.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-20 · Requirements Traceability Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eRequirement → risk → test → evidence → deviation → status.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"font-size:13px;font-weight:700;color:#075E99;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e06_Lifecycle · Lifecycle \u0026amp; Procurement\u003c\/div\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\n\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-21 · Temperature Excursion Investigation \u0026amp; CAPA\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eContainment, reconstruction, cumulative exposure, stability data, quality decision and CAPA.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-22 · Periodic Review, Maintenance \u0026amp; Requalification Planner\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eHistory, performance, changes, activities and the rationale for each due date.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-23 · Supplier RFP \u0026amp; Quality\/Service Responsibilities Checklist\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eTechnical request, documents, responsibilities, service, data, subcontractors and topics for the quality agreements.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:5px\"\u003eCC-TK-24 · Technical Bid Evaluation \u0026amp; TCO\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#536F84\"\u003eBinding requirements, bid comparison, exclusions, CAPEX and OPEX, scenario analysis.\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp style=\"margin:0 0 28px 0;font-size:14px;color:#536F84\"\u003eIn the ITA - Italiano variant the same 24 tools carry the titles of the Italian edition and the same codes CC-TK-01…24. Every tool also comes as a filled-in example on the Arvena Pharma case, in the 07_Examples folder.\u003c\/p\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#102D4F\"\u003eUse it tomorrow morning\u003c\/h3\u003e\n\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:28px\"\u003e\u003ctr style=\"background:#102D4F;color:#fff\"\u003e\u003cth style=\"text-align:left;padding:11px 13px\"\u003eThe situation\u003c\/th\u003e\u003cth style=\"text-align:left;padding:11px 13px\"\u003eWhat you use\u003c\/th\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED;vertical-align:top;width:38%\"\u003eA new cold room to specify and qualify\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED\"\u003eChapters 4, 7, 17 and 19 + CC-TK-02, CC-TK-07, CC-TK-17 and CC-TK-19: a verifiable URS, load and recovery tests, IQ\/OQ\/PQ, mapping with an acceptance zone narrowed by the uncertainty. This is Case A of Chapter 24.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED;vertical-align:top;width:38%\"\u003eMapping has to be repeated: when, and with what design\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED\"\u003eChapters 18 and 22 + CC-TK-18 and CC-TK-22: in the EU repetition follows the risk assessment or significant modifications (EU GDP §3.2.1); the interval cited by the WHO is an example, not an obligation.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED;vertical-align:top;width:38%\"\u003eAlarm thresholds and delays to justify\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED\"\u003eChapter 15 + CC-TK-15 and CC-TK-16: a time budget for each alert threshold, a tested notification and escalation chain, loss of transmission kept apart from loss of recording.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED;vertical-align:top;width:38%\"\u003ePassive shipments to hospitals\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED\"\u003eChapters 9, 10 and 12 + CC-TK-09, CC-TK-10 and CC-TK-12: lane risk, packaging qualification with justified profiles, routine control of shipments. This is Case B.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED;vertical-align:top;width:38%\"\u003eAn excursion in the warehouse or at receipt\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED\"\u003eChapter 21 + CC-TK-21, CC-TK-12 and CC-TK-03: classification, containment, reconstruction of the exposure, cumulative history of the batch, the holder's data, decision by the quality function. This is Case C.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED;vertical-align:top;width:38%\"\u003eA ULT stops at night\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED\"\u003eChapters 8 and 15 + CC-TK-08, CC-TK-15 and CC-TK-16: alternative capacity, transfer, data integrity and restoration, with the escalation chain put to the test. This is Case D.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED;vertical-align:top;width:38%\"\u003eChoosing the supplier of cold rooms, loggers or service\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED\"\u003eChapters 23 and 24 + CC-TK-23 and CC-TK-24: RFP, quality and service responsibilities, binding requirements kept apart from scores, TCO with no product loss monetised through invented values.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED;vertical-align:top;width:38%\"\u003eA GDP or GMP inspection is coming\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #D6E7ED\"\u003eChapters 20 and 24 + CC-TK-20 and CC-TK-22: requirement → test → evidence traceability, periodic review and the 40 inspector questions, built for teaching purposes, with expected evidence and red flags.\u003c\/td\u003e\u003c\/tr\u003e\u003c\/table\u003e\n\u003cdiv style=\"background:#F4FAFC;border-left:4px solid #075E99;border-radius:0 9px 9px 0;padding:20px 22px;margin-bottom:28px\"\u003e\n\u003cdiv style=\"font-weight:700;color:#075E99;font-size:16px;margin-bottom:11px\"\u003eWhat the guide does not do\u003c\/div\u003e\n\u003cdiv style=\"font-size:14.5px;color:#17354F\"\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#075E99\"\u003eIt gives no universal numbers.\u003c\/strong\u003e No universal value for permitted excursion, duration, alarm delay, number of sensors, mapping duration or frequency. Where a source writes a value, the guide reports it with document, section and nature (requirement, recommendation, example, test criterion); where no text sets it, the field stays \u0026lt;to be defined\u0026gt;.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#075E99\"\u003eIt does not confuse status and force.\u003c\/strong\u003e Every source carries a status label (current, draft, in development, superseded) and a nature label (regulatory or compendial requirement, guidance, technical standard, scientific principle, GEP\/QRM, GuideGxP recommendation), with the jurisdiction where it applies. The Annex 11 revision and the new ICH Q1 remain drafts until adopted.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#075E99\"\u003eIt does not decide on the product.\u003c\/strong\u003e The decision on a product exposed to an excursion is a documented assessment by the quality function, on the stability data of the holder or manufacturer and a complete reconstruction of the exposure: no calculation, alarm or worksheet makes it automatic.\u003c\/p\u003e\n\u003cp style=\"margin:0 0 0 0\"\u003e\u003cstrong style=\"color:#075E99\"\u003eIt does not reproduce subscription texts.\u003c\/strong\u003e USP, IATA, ISO, IEC, EN, ASTM, ISTA, ISPE and PDA are cited with title, number, edition and status; the guide describes their principles without tables or numerical criteria.\u003c\/p\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#102D4F\"\u003eContents: six parts, 24 chapters\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 14px 0;font-size:15px;color:#536F84;max-width:720px\"\u003eChapter titles of the English edition. Chapters 2-23 close with a checklist, linked tools, decisions and chapter sources.\u003c\/p\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:14px\"\u003e\n\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px 17px\"\u003e\n\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:7px\"\u003ePart I — Requirements \u0026amp; Temperature Strategy\u003c\/div\u003e\n\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#17354F\"\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e1.\u003c\/span\u003e GMP\/GDP governance and responsibilities\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e2.\u003c\/span\u003e The Product Temperature Profile\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e3.\u003c\/span\u003e The cold chain control strategy and QRM\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e4.\u003c\/span\u003e URS and verifiable requirements\u003c\/li\u003e\n\u003c\/ol\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px 17px\"\u003e\n\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:7px\"\u003ePart II — Storage Systems \u0026amp; Equipment\u003c\/div\u003e\n\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#17354F\"\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e5.\u003c\/span\u003e Selecting storage technologies\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e6.\u003c\/span\u003e Design and installation\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e7.\u003c\/span\u003e Loads and real-world operation\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e8.\u003c\/span\u003e Operational continuity\u003c\/li\u003e\n\u003c\/ol\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px 17px\"\u003e\n\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:7px\"\u003ePart III — Transport \u0026amp; Distribution\u003c\/div\u003e\n\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#17354F\"\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e9.\u003c\/span\u003e Distribution strategy and lane management\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e10.\u003c\/span\u003e Passive systems and thermal packaging\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e11.\u003c\/span\u003e Active systems and transport\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e12.\u003c\/span\u003e Shipment qualification and routine control\u003c\/li\u003e\n\u003c\/ol\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px 17px\"\u003e\n\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:7px\"\u003ePart IV — Monitoring \u0026amp; Alarm Management\u003c\/div\u003e\n\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#17354F\"\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e13.\u003c\/span\u003e Sensors, loggers and architecture\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e14.\u003c\/span\u003e Data and computerised systems\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e15.\u003c\/span\u003e The alarm strategy\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e16.\u003c\/span\u003e Trending and surveillance\u003c\/li\u003e\n\u003c\/ol\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px 17px\"\u003e\n\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:7px\"\u003ePart V — Qualification \u0026amp; Temperature Mapping\u003c\/div\u003e\n\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#17354F\"\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e17.\u003c\/span\u003e Qualification strategy\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e18.\u003c\/span\u003e Planning mapping studies\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e19.\u003c\/span\u003e Execution and data analysis\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e20.\u003c\/span\u003e Report, deviations and release\u003c\/li\u003e\n\u003c\/ol\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #D6E7ED;border-radius:10px;padding:15px 17px\"\u003e\n\u003cdiv style=\"font-weight:700;font-size:15px;color:#102D4F;margin-bottom:7px\"\u003ePart VI — Lifecycle \u0026amp; Procurement\u003c\/div\u003e\n\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#17354F\"\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e21.\u003c\/span\u003e Temperature excursions\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e22.\u003c\/span\u003e Maintenance, change control and periodic review\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e23.\u003c\/span\u003e Supplier selection and quality agreements\u003c\/li\u003e\n\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#075E99;font-weight:700\"\u003e24.\u003c\/span\u003e TCO and integrated cases\u003c\/li\u003e\n\u003c\/ol\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp style=\"margin:0 0 28px 0;font-size:14.5px;color:#17354F\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eAppendices A-F.\u003c\/strong\u003e A ITA\/ENG glossary · B Source matrix · C Chapter, toolkit and article matrix · D Toolkit instructions · E Register of assumptions and limitations · F Revision and change log.\u003c\/p\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#102D4F\"\u003eWhat the package contains\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 12px 0;font-size:15px;color:#536F84;max-width:720px\"\u003eAfter payment you download a ZIP file with the guide and the toolkit in the language of the chosen variant.\u003c\/p\u003e\n\u003cul style=\"margin:0 0 28px 0;padding-left:20px;font-size:15px;color:#17354F\"\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eThe complete PDF guide.\u003c\/strong\u003e 273 A4 pages in the Italian edition, 275 in the English one; clickable table of contents and bookmarks.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003e24 editable tools.\u003c\/strong\u003e 12 Word templates and 12 Excel workbooks, in the folders 01_Requirements…06_Lifecycle.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003e24 filled-in examples and demonstration datasets.\u003c\/strong\u003e The Arvena Pharma examples in the 07_Examples folder, with datasets DS-01…DS-06 for mapping, shipments and ULTs.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eSupport files.\u003c\/strong\u003e README, navigable toolkit index, field glossary and guide-toolkit-article matrix in the 00_Read_Me folder.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eVerification.\u003c\/strong\u003e Test Log of the Excel workbooks, language parity report, check of the example values and a manifest with the SHA-256 fingerprint of every file, in the 08_Verification folder.\u003c\/li\u003e\u003c\/ul\u003e\n\u003cdiv style=\"background:#F4FAFC;border:1px solid #D6E7ED;border-radius:12px;padding:22px 24px;margin-bottom:28px\"\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 8px 0;color:#102D4F\"\u003eRead the preview before you buy\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 16px 0;font-size:15px;color:#536F84;max-width:720px\"\u003eThe free preview is made of real pages: 16 pages in the Italian edition, 16 in the English one. It contains the introduction, the labels, the full table of contents with page numbers, the planning of a temperature mapping study from Chapter 18, the complete Case A from Chapter 24, real pages of four tools (CC-TK-12, CC-TK-15, CC-TK-18 and CC-TK-19) and the list of what the purchase includes.\u003c\/p\u003e\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px\"\u003e\n\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Cold_Chain_Preview_IT_v1.0.pdf?v=1790677340\" target=\"_blank\" rel=\"noopener\" hreflang=\"it\" style=\"display:inline-block;background:#102D4F;color:#ffffff;font-weight:700;font-size:15px;text-decoration:none;padding:12px 22px;border-radius:6px\"\u003eFree preview — Italian edition (PDF)\u003c\/a\u003e\n\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Cold_Chain_Preview_EN_v1.0.pdf?v=1790677340\" target=\"_blank\" rel=\"noopener\" hreflang=\"en\" style=\"display:inline-block;background:#ffffff;color:#102D4F;border:1.5px solid #102D4F;font-weight:700;font-size:15px;text-decoration:none;padding:11px 21px;border-radius:6px\"\u003eFree preview — English edition (PDF)\u003c\/a\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#102D4F\"\u003eSpecifications\u003c\/h3\u003e\n\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:24px\"\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eFormat\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003ePDF A4 with clickable table of contents and bookmarks; tools in .docx and .xlsx\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003ePages and chapters\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003e273 pages (ITA edition) · 275 pages (ENG edition) · 24 chapters in six parts + 6 appendices (A-F)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eToolkit\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003e24 editable tools: 12 Word + 12 Excel, codes CC-TK-01…24, plus 24 filled-in examples\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eLanguage of the files\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003eOne language per purchase: \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e or \u003cstrong\u003eENG - English\u003c\/strong\u003e. No files exist in French, German or Spanish.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eEdition and revision\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003eFirst edition, September 2026 · revision v1.0 · tools Rev. 1.0\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eRegulatory verification\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003e28\/09\/2026 (status of every source at that date)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eSources and decisions\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003e89 sources in the register · 113 tracked decisions\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eFree preview\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003e16 pages (ITA edition) · 16 pages (ENG edition)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eDelivery\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003eDigital product: ZIP download after payment. Nothing is shipped: the 3D image of the volume is a graphic representation, there is no printed book.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eSoftware requirements\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003eA PDF reader; Microsoft Word and Excel (formulas compatible with Excel 2016 and later) or compatible programs: the Excel workbooks were recalculated with LibreOffice in the Test Log runs. No macros, no external links.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F4FAFC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003eLicence\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003eIndividual use, internal to the purchasing company: a personal, non-exclusive and non-transferable licence of use, under the site's Legal notice; printing for internal use only; sharing the files with third parties is prohibited.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED;width:32%;font-weight:600;color:#102D4F;vertical-align:top\"\u003ePrice\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #D6E7ED\"\u003e€199.00 per variant (guide + toolkit in the chosen language)\u003c\/td\u003e\u003c\/tr\u003e\u003c\/table\u003e\n\u003cdiv style=\"background:#FFFFFF;border:1px solid #D6E7ED;border-left:4px solid #102D4F;border-radius:0 11px 11px 0;padding:18px 22px 6px 22px;margin-bottom:28px\"\u003e\n\u003cdiv style=\"font-weight:700;color:#102D4F;font-size:16px;margin-bottom:10px\"\u003eLimits of use\u003c\/div\u003e\n\u003cul style=\"margin:0 0 10px 0;padding-left:20px;font-size:15px;color:#17354F\"\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eThe Excel workbooks are calculation models with a specification, tests and limits, \u003cstrong\u003enot GMP-validated software\u003c\/strong\u003e: before GxP use the company verifies them within its own system, repeating the Test Log cases.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eThe Arvena Pharma examples are for demonstration: the company is fictitious, the data are hypothetical and they are neither acceptance criteria nor data from a real product.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eNo worksheet decides on the product: the outputs are only \"Comparison with the entered criteria\" or \"Quality assessment required\". The guide does not replace the assessment of the quality function.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eThe guide does not replace the official texts it cites and is not personalised legal, regulatory or quality advice.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eNo guarantee of any audit or inspection outcome, which depends on the context and on how the guide is applied.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eThe guide and the toolkit have not undergone independent third-party validation; the examples were recalculated independently by the editorial team.\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"background:#F4FAFC;border:1px solid #D6E7ED;border-radius:11px;padding:18px 21px;margin-bottom:28px;font-size:14.5px;color:#17354F\"\u003e\n\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eWho it is for.\u003c\/strong\u003e QA, GDP Responsible Persons, Engineering, Validation and CQV, Supply Chain, warehouse, logistics, procurement, maintenance and owners of monitoring systems. It is written for people who \u003cstrong\u003especify, qualify or run cold rooms, refrigerators, freezers, ULTs and shipments\u003c\/strong\u003e and need to know which text every value comes from, with what force and in which market.\u003c\/p\u003e\n\u003cp style=\"margin:0\"\u003e\u003cstrong style=\"color:#102D4F\"\u003eWho it is not for.\u003c\/strong\u003e It is not a guide to the role of the GDP Responsible Person, to cleanroom HVAC, to the analytical stability programme, to dangerous goods (dry ice appears only as a refrigerant), to freeze-drying or to ATMP manufacturing: these subjects stay in the sister guides or outside the scope.\u003c\/p\u003e\u003c\/div\u003e\n\u003ch3 style=\"font-size:22px;margin:0 0 12px 0;color:#102D4F\"\u003eFrequently asked questions\u003c\/h3\u003e\n\u003cdiv style=\"margin-bottom:28px\"\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eIn which language do I receive the files?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eIn the language of the chosen variant: \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e or \u003cstrong\u003eENG - English\u003c\/strong\u003e. Each purchase includes the guide and the toolkit in one language. No files exist in French, German or Spanish.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eIs it a printed book?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eNo. It is a digital product: after payment you download a ZIP file with the PDF and the tools. Nothing is shipped; the 3D image only represents the volume.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eDoes the guide give a mapping duration, a number of sensors or alarm delays valid for everyone?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eNo, because no regulation sets them. It reports the values the sources write, with their nature, and the method to decide and justify the company's own, each with its decision code (Chapters 15, 18 and 19).\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eDo the workbooks say whether a product can be released after an excursion?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eNo. They return only \"Comparison with the entered criteria\" or \"Quality assessment required\". The decision stays with the quality function, on the stability data of the holder or manufacturer (Chapter 21, CC-TK-21).\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eAre the Excel workbooks validated?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eThey are not GMP-validated software. Each one has a specification, formulas written out in plain text, error checks and a Test Log of the tests executed: the company verifies them within its own system before GxP use.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eWhat software do I need?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eA PDF reader and Microsoft Word and Excel or compatible programs. The formulas are compatible with Excel 2016 and later and the workbooks were recalculated with LibreOffice in the tests; there are no macros and no external links.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eCan I share the files with colleagues or suppliers?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eThe licence covers individual use, internal to the purchasing company, and is personal, non-exclusive and non-transferable: sharing the files with third parties, including suppliers and external consultants, is prohibited. Printing is allowed for internal use only.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eWhat happens when the reference texts change?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eAppendix F lists the events that trigger a re-verification of the guide: adoption of ICH Q1 at Step 4, planned by ICH for November 2026, the final texts of the revision of EU GMP Annex 11 and Chapter 4, and the 15th edition of the IATA Temperature Control Regulations, planned for 2027. When the texts change, you receive the revised guide and toolkit at no extra cost. The appendix announces no revision dates: the revision on sale is stated on this page.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eDoes it also cover the GDP Responsible Person and HVAC?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eOnly as interfaces. The role of the Responsible Person, cleanroom HVAC, environmental monitoring and computer system validation are covered in the sister guides listed in the front matter.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"border-bottom:1px solid #D6E7ED;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#102D4F\"\u003eDoes it apply in the United States?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#17354F\"\u003eThe main reference is the EU (EU GDP, EudraLex, Annex 15), with WHO and PIC\/S as guidance; for the United States the guide gives the essential status of 21 CFR and of the informational USP chapters of the \u0026lt;1079\u0026gt; series, without reproducing their text.\u003c\/p\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"background:#F4FAFC;border:1px solid #D6E7ED;border-radius:12px;padding:20px 24px;margin-bottom:16px\"\u003e\n\u003cdiv style=\"font-size:17px;font-weight:700;color:#102D4F;margin-bottom:6px\"\u003eBefore you buy: the Cold Chain hub\u003c\/div\u003e\n\u003cp style=\"margin:0 0 12px 0;font-size:15px;color:#17354F\"\u003eThe 12 technical articles of the Cold Chain \u0026amp; Controlled Temperature Systems hub introduce the six areas of the guide, from requirements to supplier selection.\u003c\/p\u003e\n\u003ca href=\"https:\/\/www.guidegxp.com\/pages\/cold-chain-controlled-temperature-systems\" style=\"color:#075E99;font-weight:700;font-size:15px\"\u003eGo to the Cold Chain hub →\u003c\/a\u003e\u003c\/div\u003e\n\u003cdiv style=\"background:#102D4F;border-radius:12px;padding:24px 26px;color:#fff;margin-bottom:20px\"\u003e\n\u003cdiv style=\"font-size:18px;font-weight:700;margin-bottom:8px;color:#ffffff\"\u003eDo you need to qualify a cold room, a lane or a monitoring system?\u003c\/div\u003e\n\u003cdiv style=\"font-size:15px;color:#DDEBF3;margin-bottom:16px;max-width:660px\"\u003eDescribe the system, the products, the authorised conditions and where you are stuck. GuideGxP will review the request and, where appropriate, may put you in touch with a specialist matching your technical needs and your geographical area.\u003c\/div\u003e\n\u003ca href=\"https:\/\/www.guidegxp.com\/pages\/expert-support?area=cold-chain-controlled-temperature\u0026amp;source=product-cold-chain-guide\u0026amp;cta=product-page\" style=\"display:inline-block;background:#BCD4E4;color:#102D4F;font-weight:700;font-size:15px;text-decoration:none;padding:11px 22px;border-radius:6px\"\u003eDescribe the situation →\u003c\/a\u003e\n\u003cdiv style=\"font-size:12.5px;color:#DDEBF3;margin-top:12px\"\u003eNo purchase obligation. The request is reviewed before any referral to a specialist.\u003c\/div\u003e\u003c\/div\u003e\n\u003cp style=\"font-size:12.5px;color:#536F84;margin:0\"\u003eGuideGxP guides do not replace official regulations or the guidance and standards they cite (European Commission, EMA, WHO, PIC\/S, FDA, ICH, MHRA, Health Canada, Swissmedic, EDQM, USP, IATA, ISO\/EN\/IEC): they are operational support tools, not legal advice, and the user remains responsible for the correct application of the regulations in force in their own company context. Subscription texts are not reproduced. Numerical examples are for demonstration only and are not acceptance criteria; the decision on the product rests with the quality function. Regulatory status verified as of 28\/09\/2026. Arvena Pharma is a fictitious company. Digital product: nothing is physically shipped.\u003c\/p\u003e\n\u003c\/div\u003e","brand":"GuideGxP","offers":[{"title":"ITA - Italiano","offer_id":63733199569226,"sku":null,"price":199.0,"currency_code":"EUR","in_stock":true},{"title":"ENG - English","offer_id":63733199601994,"sku":null,"price":199.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Cold_Chain_Cover_EN_v1.0_9c3903fd-4b8f-44db-b86a-0ff1589c1498.png?v=1790689486","url":"https:\/\/www.guidegxp.com\/products\/cold-chain-controlled-temperature-gmp-gdp-guide","provider":"GuideGxP","version":"1.0","type":"link"}