Third edition · Rev. 3.0 · regulatory verification 29/09/2026
From batch to signature: which text governs each point of certification, with what legal force, in which jurisdiction, and where the QP's decision is recorded.
An operational guide for those who certify batches or feed certification: EU legal basis, Annex 16 clause by clause, agreements and supply chain, unexpected deviations, multi-site confirmations, importation, MRAs, remote certification, IMPs, disposition and release, with the United Kingdom, Italy and a comparison with the United States. 25 chapters in six parts, 5 appendices and 24 editable tools in Word and Excel.
259 pages (ENG) · 259 (ITA) · A4 PDF25 chapters in six parts + 5 appendices24 tools: 6 Word + 18 Excel117 source IDs in the register8 legal-force labelsDigital product: download after payment
One language per purchase, chosen by the variant. The ENG - English variant gives you the PDF guide and the 24 tools in English; the ITA - Italiano variant gives them in Italian. Both editions have the same structure, the same tools and the same QP-TK-01…24 codes. There are no French, German or Spanish files.
What has changed since Rev. 2.0
Rev. 3.0 is a rewritten third edition, not a set of corrections. Rev. 2.0 (August 2026) had an evidence cut-off of 03/08/2026; since then the status of Annex 19 and of the pharmaceutical package has changed, and other gaps in that edition were structural. If you own Rev. 2.0, this is what you will find different.
| Topic | Rev. 2.0 (August 2026) | Rev. 3.0 (verified 29/09/2026) |
|---|
| Structure | 13 chapters, six appendices | 25 chapters in six parts, Appendices A–E |
| Annex 16 point by point | §1.7 cited as a range; Appendix I and II not reproduced | §1.6 and §1.7.1–1.7.21 clause by clause; Appendix I (QP confirmation) and Appendix II (batch certificate) |
| Annex 19 | readiness source, not yet applicable | revised Annex 19 applicable from 24/09/2026, with a dedicated chapter |
| EU pharmaceutical package | provisional agreement | Council first-reading position of 28/09/2026; text not adopted, discussed only in conditional form, with the correlation table in Appendix B |
| MRAs and ACAA | human medicines only; no table by partner | EU QP relieved of batch testing for covered veterinary products from 29/05/2026; one table by partner with form, dates, IMPs and exclusions |
| United Kingdom, Italy, USA | UK and Italy in short appendices; USA absent | three chapters: GB and Northern Ireland (SI 2025/538, Windsor Framework, RPi), Italy (Article 52 of Legislative Decree 219/2006, GMPMED), United States (quality control unit and 21 CFR), plus a synoptic comparison |
| QP qualification and delegation | not covered | Article 49 in a table, three levels of delegation, discipline |
| Topics previously only mentioned | QP declaration, IMPs, safety features and remote certification referred to in general terms | dedicated chapters with the reference documents, the conditions of the July 2023 EMA Q&A and the positions of Italy, Ireland and GB |
| Labels | five status markers | eight legal-force labels, one per line |
| Toolkit and examples | 15 tools in two working files; cases unconnected across chapters | 24 tools QP-TK-01…24, one file per tool, Word templates included; a single fictitious dataset (Tavenzia Pharma) for book and toolkit |
Rev. 2.0 should no longer be used as an operational reference. The front matter of the guide gives the full comparison, with the chapter that deals with each change.
The problems it tackles
The misconceptions the guide takes apart, each traced to a text with its source ID, its status and its legal force in the jurisdiction where it applies.
A batch marked "released" that means three things. QP certification, the batch disposition decision and release for sale or supply each have their own owner, record and stop state. Chapter 1 separates them into three gates; QP-TK-11 reconciles them.
"With an MRA you don't need a QP." An MRA relieves the QP of responsibility for the Article 51(1) controls of Directive 2001/83/EC; it does not relieve the QP of certifying each batch (Chapter 14).
"The QP delegates certification." QP responsibilities may be delegated only to other QPs; the Annex 16 §1.7 activities to trained personnel or third parties; the §1.6 checks the QP ensures personally (Chapters 3 and 7).
"Annex 16 is about to change." The 2015 Annex 16 is in force: as of 29/09/2026 no draft revision has been published for consultation, and Annex 16 is absent from the IWG work plan 2026–2028 (Chapters 2 and 25).
"The pharmaceutical package applies from…" As of 29/09/2026 there is the Council first-reading position of 28/09/2026: the acts are not adopted, not published in the Official Journal and have no number. The guide discusses them only in the conditional, for readiness (Chapter 25).
"The rule is the same everywhere." The United Kingdom is not an MRA partner and has the RPi; in Italy the QP works within Article 52 of Legislative Decree 219/2006; the United States has no QP but a quality control unit (Chapters 21–24).
Values "required by law" that no source sets. QP presence on site, audit frequency, the number of batches for a comparative study, escalation times, KPI thresholds: the guide leaves them <to be defined> in the PQS and explains who decides, on what evidence and in which record.
The guide
25 chapters in six parts, each built on a question the QP has to settle, and 5 appendices. Every regulatory statement carries one of the eight legal-force labels and a source ID with its article or paragraph; Appendix D resolves the 117 IDs. Chapters 1–24 contain a guided case (Problem → Risk → Decision → Activities → Documentation → Evidence → Outcome), inspector questions with expected evidence and red flags, and an operational checklist.
The toolkit
24 tools: 6 Word templates and 18 Excel workbooks, one file per tool, with the same QP-TK code as in the book. The Excel workbooks have README, PARAMETERS, TEMPLATE, EXAMPLE, TEST and SOURCES sheets; parameters that no source sets stay empty and block the outcomes that depend on them. No tool calculates a certification outcome: each one records the QP's decision or prepares the QP's review.
One case, from start to finish
The fictitious company Tavenzia Pharma has four sites (Italy, Ireland, United States, Great Britain), three products (a film-coated tablet, a monoclonal antibody in a prefilled syringe and an investigational medicinal product) and eight batches that run through the chapters and the EXAMPLE sheets of the toolkit. Its figures are declared fictitious and are not recommendations.
Regulatory status verified as of 29/09/2026
Every verb in the present tense in the guide describes the state of the sources as of 29/09/2026. The points that most often change how a source is read:
- Annex 16: the 2015 text, operational since 15/04/2016, is the one in force; no draft revision has been published for consultation.
- Revised Annex 19 (C(2026) 4135 of 23/06/2026): applies from 24/09/2026; the 2005/2006 version is no longer in force.
- EU pharmaceutical package: Council first-reading position of 28/09/2026 (ST 7106/2/26 REV 2 and ST 7105/2/26 REV 2). Approval by the European Parliament is still needed; the acts are neither adopted nor in force.
- EudraLex drafts: Ch. 1, Ch. 4, Annex 11 and the new Annex 22 remain drafts with closed consultations; the 2013 Ch. 1 and the 2011 Ch. 4 and Annex 11 remain in force.
- EU-US MRA: from 29/05/2026 EU QPs are relieved of batch testing for covered veterinary products.
Updates included. The guide lists the events that call for a fresh verification of status: publication of the pharmaceutical package in the Official Journal, final texts of Ch. 1, Ch. 4, Annex 11 and Annex 22, any draft revision of Annex 16, updates to the GB approved-country lists. When the texts change you receive the revised guide and toolkit at no extra cost.
The 24 tools, in six groups
Exact titles of the English edition, grouped by stage of the certification process. No operational value that a source does not fix is preloaded: where one is needed, the field stays <to be defined>, with who decides, the basis of the choice and the approval date.
Applicability and the QP's role · Chapters 2–4
EXCELQP-TK-01 · Applicability, Source Status and Horizon Scanning Register
Classifies each batch branch (product × market × route) and keeps a dated record of source status, with re-verification triggers.
WORDQP-TK-02 · QP Charter: Mandate, Scope, Deputy and Decision Rights
Three levels of delegation, interfaces, deputy, escalation and, for an Italian site, the Article 52 section.
EXCELQP-TK-03 · QP Qualification and Experience File
Degree, course length, subjects and experience checked against Article 49 and the Italian and UK rules; it does not replace recognition by the authority.
EXCELQP-TK-04 · GB / NI / EU Route and RPi Checker
Routes to Great Britain and Northern Ireland, "UK Only" packs and the evidence the RPi needs.
Agreements, supply chain and evidence · Chapters 5–7
WORDQP-TK-05 · QP Schedule to the Technical Agreement
Operations, sites, records, deviations, changes, confirmations, samples and the certifying QP's access to data and systems.
EXCELQP-TK-06 · Supply Chain, Sites, Authorisations and Due Dates Map
Route nodes with authorisations, certificates, agreements, audits and written confirmations, flagging whatever is missing.
EXCELQP-TK-07 · Audit Register and QP Written Final Assessment
Scope, conflicts of interest, auditor recommendation and final assessment: it shows whether the audit raises an impediment, never "certify".
WORDQP-TK-08 · Active Substance QP Declaration Support Dossier
When it is needed, who signs, audit basis and exclusions, with the references to the EMA documents.
EXCELQP-TK-09 · Annex 16 §1.7.1–1.7.21 Evidence Index by Route
The 21 §1.7 rows per batch, with justified applicability, evidence, owner, reviewer and status.
Certification, register, confirmations and samples · Chapters 8–12
WORDQP-TK-10 · QP Decision Record, Batch Certificate and QP Confirmation
The decision with its rationale, the Appendix II certificate and the Appendix I confirmation.
EXCELQP-TK-11 · Certification Register and Three-Gate Reconciliation
Certification, disposition and availability for sale reconciled batch by batch, with calculated retention periods.
EXCELQP-TK-12 · Unexpected Deviation: Eligibility Gate and Assessment
The Annex 16 §3 gate: it shows when the unexpected-deviation route does not apply and which route to follow instead.
EXCELQP-TK-13 · QP Confirmation Pack and Multi-Site Reliance
One row per route operation: confirmation, Appendix I elements, evidence of execution and assurance.
EXCELQP-TK-18 · Reference and Retention Samples (revised Annex 19)
Sample inventory with location, agreements and retention dates calculated under the revised Annex 19.
Importation, MRAs, remote certification and IMPs · Chapters 13–17
EXCELQP-TK-14 · Import Route and Annex 21
Site of physical importation, site of certification, import testing and Annex 21 evidence.
EXCELQP-TK-15 · MRA/ACAA and Batch Certificate Checker
Partner, scope, exclusions and the manufacturer's batch certificate: what the MRA exempts and what it does not.
EXCELQP-TK-16 · Third-Country Sampling and Results Comparison
The Annex 16 §1.5.5–1.5.7 conditions documented, and results compared against a local limit still to be defined.
WORDQP-TK-17 · Remote Certification Assessment
Position of the site's authority, EMA Q&A conditions, systems, data access and a reasoned decision.
EXCELQP-TK-19 · IMP Gate Register
QP certification and the sponsor's regulatory release by batch and by country, under the CTR and Delegated Regulation 2017/1569.
After certification and inspection · Chapters 18–20
EXCELQP-TK-20 · Post-Certification Event, Quality Defect and Market Action
Signals, assessment, communications and batch population, without rewriting the certification record.
EXCELQP-TK-21 · Certification Process Self-Inspection
The CL rows of the chapter checklists, with actions and effectiveness: a closure without verified effectiveness stays flagged.
EXCELQP-TK-22 · Diagnostic KPI Dashboard and 30/60/90 Plan
Diagnostic KPIs with their own numerator, denominator and anti-gaming rule, thresholds left to the company and an action plan in three windows: 30, 60 and 90 days.
WORDQP-TK-23 · SOP "QP Certification and Batch Release"
A procedure with fixed sections: responsibilities, standard route, exceptions, stop states, records and references.
Regulatory horizon · Chapter 25
EXCELQP-TK-24 · EU Pharmaceutical Reform Readiness Check
Today and the Council text side by side, area by area, to plan preparation: the file carries the DRAFT marking.
In the ITA - Italiano variant the same 24 tools carry the titles of the Italian edition and the same QP-TK-01…24 codes. Each Excel workbook contains an EXAMPLE sheet filled in with the Tavenzia Pharma case; each Word file has an EXAMPLE annex, with the banner "FICTITIOUS EXAMPLE — DO NOT USE OPERATIONALLY".
Use it tomorrow morning
| The situation | What you use |
|---|
| The batch shows as "released" in the system, but no disposition is recorded | Chapters 1, 8 and 18 + QP-TK-11 and QP-TK-23: three gates with owner, record and stop state, and batch-by-batch reconciliation. |
| Preparing the evidence dossier for signature | Chapter 7 + QP-TK-09 and QP-TK-10: clauses §1.7.1–1.7.21 by route, with justified applicability, decision record and batch certificate. |
| An unexpected deviation before certification | Chapter 11 + QP-TK-12: the Annex 16 §3 gate, the cases where it does not apply and the QP's documented assessment. |
| A batch manufactured in the United States and imported into the EU | Chapters 13 and 14 + QP-TK-14, QP-TK-15 and QP-TK-16: Annex 21, MRA scope, third-country sampling only under the Annex 16 conditions. |
| Shipments to Great Britain or Northern Ireland | Chapter 22 + QP-TK-04: recognised routes, "UK Only" packs, evidence for the RPi. |
| A request to certify remotely | Chapter 15 + QP-TK-17: conditions of the July 2023 EMA Q&A, positions of Italy, Ireland and GB, data integrity. |
| Reference and retention samples after 24/09/2026 | Chapter 9 + QP-TK-18: the revised Annex 19, sample location and written agreements. |
| A clinical trial with batches to certify | Chapter 17 + QP-TK-19: QP certification and the sponsor's regulatory release, as two distinct steps. |
| A new QP at an Italian site | Chapters 3 and 21 + QP-TK-02 and QP-TK-03: Article 52 requirements, eligibility through the GMPMED online service, replacement of the QP. |
| Preparing the organisation for the EU reform | Chapter 25 and Appendix B + QP-TK-24: readiness against the Council text, without treating it as an obligation. |
What the guide does not do
It does not invent numbers. No universal value for presence on site, audit frequency, number of batches, escalation time or KPI threshold. Values that a source fixes appear with their ID; the rest stay <to be defined> in the PQS, on the basis of a documented risk assessment.
It does not treat drafts as law. The drafts of Ch. 1, Ch. 4, Annex 11 and Annex 22 and the Council text carry the [DRAFT] label: they serve to prepare readiness, not to drive a current decision.
It does not decide for the QP. The certification of each batch remains an act of the QP; downstream decisions remain with the persons designated by the MIA holder. No tool returns "certify".
It is not legal advice. It describes texts, status and legal force of sources; quotations are short and verbatim, legal provisions are paraphrased.
Contents: six parts, 25 chapters
Chapter titles of the English edition. Every chapter closes with the inspector questions, the operational checklist and the toolkit tools with the chapter sources.
Part I — The QP in EU law
- 1. The batch in three gates: certification, disposition, release
- 2. The EU legal basis of certification
- 3. QP qualification, availability, delegation and discipline
- 4. Applicability, jurisdictions and source status
Part II — The certification system
- 5. PQS, technical agreements and contracts
- 6. Supply chain, active substances and third-party audits
- 7. Annex 16 §1.7.1–1.7.21 clause by clause
- 8. Workflow, register and batch certificate
- 9. Reference and retention samples (revised Annex 19)
- 10. Safety features and certification
Part III — Exceptions and complex routes
- 11. Unexpected deviations
- 12. QP confirmations, multi-site and outsourcing
- 13. Importation and Annex 21
- 14. MRAs, ACAA and batch certificates
- 15. Remote certification, digital systems and data integrity
- 16. Products with special pathways
- 17. Investigational medicinal products (IMPs)
Part IV — After certification
- 18. Disposition, release and the GDP interface
- 19. New signals, quality defects and recalls
- 20. Self-inspection and inspection readiness
Part V — National overlays and comparisons
- 21. Italy: the Qualified Person under Legislative Decree 219/2006
- 22. United Kingdom: Great Britain and Northern Ireland
- 23. United States: batch release without a QP
- 24. Synoptic comparison EU – UK – Italy – US
Part VI — Regulatory horizon
- 25. The EU pharmaceutical reform and other ongoing revisions
Appendices A–E. A Full map of Annex 16 · B Correlation table Directive 2001/83/EC ↔ Council text · C ITA–ENG glossary · D Source register (117 IDs) · E Toolkit index.
What the package contains
After payment you download the guide and the toolkit in the language of the variant you chose.
- The complete PDF guide. 259 A4 pages in the English edition, 259 in the Italian edition; clickable table of contents and bookmarks.
- 18 Excel workbooks (.xlsx). README, PARAMETERS, LISTS, TEMPLATE, EXAMPLE, TEST and SOURCES sheets; calculated cells protected without a password, to prevent errors; no macros, no external links.
- 6 Word templates (.docx). Document control with empty fields, tool-specific instructions, stable numbered sections, change log and EXAMPLE annex.
- One file per tool. File names and QP-TK codes match Appendix E, which lists every tool with its format and linked chapters.
Read the preview before you buy
The free preview is made of real pages of the guide: 16 pages in the English edition, 16 in the Italian edition.
Specifications
| Format | A4 PDF with clickable table of contents and bookmarks; tools in .docx and .xlsx |
| Pages and chapters | 259 pages (ENG edition) · 259 pages (ITA edition) · 25 chapters in six parts + 5 appendices (A–E) |
| Toolkit | 24 editable tools: 6 Word + 18 Excel, codes QP-TK-01…24, one file per tool |
| File languages | One language per purchase: ENG - English or ITA - Italiano. There are no French, German or Spanish files. |
| Edition and revision | Third edition · October 2026 · Rev. 3.0 · tools rev. 1.0; supersedes Rev. 2.0 (August 2026) |
| Regulatory verification | 29/09/2026 (status of every source on that date) |
| Jurisdictions | EU/EEA · United Kingdom (Great Britain and Northern Ireland) · Italy · US comparison |
| Sources and labels | 117 source IDs in the Appendix D register · 8 legal-force labels |
| Free preview | 16 pages (ENG edition) · 16 pages (ITA edition) |
| Updates | When the texts change you receive the revised guide and toolkit at no extra cost. |
| Delivery | Digital product: download after payment. Nothing is shipped: the 3D image of the volume is a graphic rendering, there is no printed book. |
| Software requirements | A PDF reader; Microsoft Word and Excel (formulas compatible with Excel 2016 and later) or compatible programs: the Excel workbooks were recalculated in LibreOffice during testing. No macros, no external links. |
| Licence | Individual use and internal use within the purchasing company: a personal, non-exclusive, non-transferable licence under the site's Legal Notice; printing for internal use only; sharing the files with third parties is not permitted. |
Limits of use
- The Excel workbooks are calculation templates with test sheets, not GMP-validated software: before GxP use the company verifies them in its own system by repeating the cases on the TEST sheet.
- Tavenzia Pharma is a fictitious company: entities, people, products, batches, dates and figures are invented and are neither criteria nor data of a real company.
- No tool calculates a certification outcome: each one records the QP's decision or prepares the QP's review.
- The guide does not replace the official texts it cites and is not personalised legal, regulatory or quality advice.
- The inspector questions are constructed for teaching purposes and anchored to the texts cited; they do not reproduce questions from any authority. No outcome of audits or inspections is guaranteed.
Who it is for. QPs in post or in training, deputy QPs, QA Managers and Heads of Quality at MIA sites, certification process owners, Regulatory Affairs, import and supply chain managers, UK QPs and RPis, quality units of US companies supplying the EU, auditors and consultants. It assumes the reader knows GMP and a batch record.
Who it is not for. It does not cover veterinary medicinal products (apart from the EU-US MRA provisions) or the national positions of Member States other than Italy and Ireland. Data integrity governance, the general deviation and CAPA system, the role of the GDP Responsible Person, computerised system validation, cold chain and stability programme design stay in the sister guides: here only the aspects that certification needs appear.
Frequently asked questions
In which language do I receive the files?
In the language of the variant you choose: ENG - English or ITA - Italiano. Each purchase includes the guide and the toolkit in a single language. There are no French, German or Spanish files.
I own Rev. 2.0: what has changed?
Rev. 3.0 is a rewritten third edition: 25 chapters instead of 13, 24 tools in separate files instead of 15 in two working files, Annex 16 clause by clause, the revised Annex 19 applicable from 24/09/2026, the pharmaceutical package as it stood on 28/09/2026, and dedicated chapters on the United Kingdom, Italy and the United States. The table on this page summarises the differences; Rev. 2.0 should no longer be used as an operational reference.
Do the tools tell me whether the batch can be certified?
No. No tool returns "certify": the outcomes flag gaps, stop states, inconsistencies or undefined parameters, and the record documents the QP's decision.
Is the pharmaceutical package treated as if it were already in force?
No. As of 29/09/2026 there is the Council first-reading position of 28/09/2026; the acts are neither adopted nor published. Chapter 25, Appendix B and QP-TK-24 discuss it only in conditional form, for readiness.
Does it cover the United Kingdom and the United States?
Yes, with dedicated chapters. For Great Britain and Northern Ireland: SI 2025/538, the Windsor Framework, permanent acceptance of EU/EEA certification in GB, the RPi and the 2025 QP Code of Practice. For the United States: the quality control unit and 21 CFR Parts 210 and 211, plus a four-jurisdiction synoptic comparison.
Does it apply to veterinary medicinal products?
No. The guide covers medicinal products for human use; for veterinary products it reports only the EU-US MRA provisions.
Are the Excel workbooks validated?
They are not GMP-validated software. Each one has a TEST sheet with test cases, expected result and calculated result, and a SOURCES sheet with the IDs used: the company verifies them in its own system before GxP use.
What happens when the reference texts change?
The guide's Regulatory Status Box lists the events that call for a fresh verification, starting with publication of the pharmaceutical package in the Official Journal and the final texts of Ch. 1, Ch. 4, Annex 11 and Annex 22. When the texts change you receive the revised guide and toolkit at no extra cost. The revision on sale is shown on this page, with the date of the regulatory verification.
Is it a printed book?
No. It is a digital product: after payment you download the PDF and the tools. Nothing is shipped; the 3D image only represents the volume.
Can I share the files with colleagues at other companies or with consultants?
The licence covers individual use and internal use within the purchasing company; it is personal, non-exclusive and non-transferable: sharing the files with third parties, including suppliers and external consultants, is not permitted. Printing is allowed for internal use only.
Do you have a batch, a route or a delegation to sort out?
Describe the product, the route, the jurisdictions involved and the point where you are stuck. GuideGxP will review the request and, where appropriate, may put you in touch with a specialist suited to your technical needs and your geographical area.
Describe your situation →No purchase required. Each request is reviewed before any referral to a specialist.
GuideGxP guides do not replace official legislation or the guidance and standards they cite (European Commission, EMA, PIC/S, MHRA, AIFA, HPRA, FDA): they are operational support tools, they are not legal advice, and users remain responsible for correctly applying the rules in force in their own company context. The certification of each batch remains an act of the QP. The drafts and the Council text on the pharmaceutical package are not adopted and are marked as such. Regulatory status verified as of 29/09/2026. Tavenzia Pharma is a fictitious company. Digital product: nothing is shipped.
