{"title":"ANNEX 1 EU GMP – Guide Operative per la Produzione Sterile","description":"\u003cp data-start=\"151\" data-end=\"399\"\u003eLa collezione \u003cstrong data-start=\"165\" data-end=\"183\"\u003eANNEX 1 EU GMP\u003c\/strong\u003e raccoglie guide operative dedicate all’implementazione dei requisiti GMP per la \u003cstrong data-start=\"264\" data-end=\"300\"\u003eproduzione di medicinali sterili\u003c\/strong\u003e, in linea con l’\u003cstrong data-start=\"317\" data-end=\"347\"\u003eAnnex 1 EU GMP (Rev. 2022)\u003c\/strong\u003e e le aspettative ispettive di \u003cstrong data-start=\"378\" data-end=\"398\"\u003eEMA. AIFA, FDA e PIC\/S\u003c\/strong\u003e. Le guide trasformano la normativa in \u003cstrong data-start=\"438\" data-end=\"510\"\u003eprocessi applicabili, documentazione audit-ready e strumenti pratici\u003c\/strong\u003e, con focus su \u003cstrong data-start=\"525\" data-end=\"565\"\u003eContamination Control Strategy (CCS)\u003c\/strong\u003e, \u003cstrong data-start=\"567\" data-end=\"603\"\u003eQuality Risk Management (ICH Q9)\u003c\/strong\u003e e integrazione nel \u003cstrong data-start=\"623\" data-end=\"666\"\u003ePharmaceutical Quality System (ICH Q10)\u003c\/strong\u003e.\u003c\/p\u003e","products":[{"product_id":"guida-operativa-all-implementazione-dell-annex-1-eu-gmp-rev-2022","title":"Guida Operativa all’Implementazione dell’Annex 1 EU GMP (Rev. 2022)","description":"\u003cp data-end=\"543\" data-start=\"267\"\u003eL’\u003cstrong data-end=\"304\" data-start=\"269\"\u003eAnnex 1 EU GMP (Revisione 2022)\u003c\/strong\u003e introduce un cambio di paradigma nella produzione di medicinali sterili, rafforzando l’approccio \u003cstrong data-end=\"416\" data-start=\"402\"\u003erisk-based\u003c\/strong\u003e, l’integrazione nel \u003cstrong data-end=\"470\" data-start=\"437\"\u003ePharmaceutical Quality System\u003c\/strong\u003e e l’obbligo di una \u003cstrong data-end=\"530\" data-start=\"490\"\u003eContamination Control Strategy (CCS)\u003c\/strong\u003e strutturata. Questa guida operativa supporta l’\u003cstrong data-end=\"619\" data-start=\"579\"\u003eimplementazione pratica dell’Annex 1\u003c\/strong\u003e, trasformando i requisiti normativi in \u003cstrong data-end=\"728\" data-start=\"659\"\u003eprocessi operativi, controlli documentati e strumenti audit-ready\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch2 data-end=\"764\" data-start=\"736\"\u003eCosa troverai nella guida\u003c\/h2\u003e\n\u003cp data-end=\"865\" data-start=\"766\"\u003eLa guida copre in modo strutturato tutti i requisiti chiave dell’Annex 1 (Rev. 2022), con focus su:\u003c\/p\u003e\n\u003ch3 data-end=\"907\" data-start=\"867\"\u003eContamination Control Strategy (CCS)\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli data-end=\"943\" data-start=\"910\"\u003estruttura e contenuti della CCS\u003c\/li\u003e\n\u003cli data-end=\"995\" data-start=\"946\"\u003eintegrazione con processi, impianti e personale\u003c\/li\u003e\n\u003cli data-end=\"1049\" data-start=\"998\"\u003ecollegamento con Quality Risk Management (ICH Q9)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-end=\"1081\" data-start=\"1051\"\u003eApproccio risk-based e PQS\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli data-end=\"1126\" data-start=\"1084\"\u003eapplicazione pratica del risk assessment\u003c\/li\u003e\n\u003cli data-end=\"1174\" data-start=\"1129\"\u003eintegrazione dell’Annex 1 nel PQS (ICH Q10)\u003c\/li\u003e\n\u003cli data-end=\"1222\" data-start=\"1177\"\u003eprevenzione dei finding più comuni in audit\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-end=\"1251\" data-start=\"1224\"\u003eAree operative critiche\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli data-end=\"1295\" data-start=\"1254\"\u003e\u003cstrong data-end=\"1293\" data-start=\"1254\"\u003ePersonale e comportamento in asepsi\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli data-end=\"1325\" data-start=\"1298\"\u003e\u003cstrong data-end=\"1323\" data-start=\"1298\"\u003eLocali, HVAC e flussi\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli data-end=\"1393\" data-start=\"1328\"\u003e\u003cstrong data-end=\"1391\" data-start=\"1328\"\u003eAttrezzature e tecnologie (isolatori, RABS, sistemi chiusi)\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli data-end=\"1424\" data-start=\"1396\"\u003e\u003cstrong data-end=\"1422\" data-start=\"1396\"\u003eMateriali e componenti\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli data-end=\"1476\" data-start=\"1427\"\u003e\u003cstrong data-end=\"1474\" data-start=\"1427\"\u003eEnvironmental Monitoring e Media Fill 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prodotto\u003c\/h2\u003e\n\u003cp data-start=\"1324\" data-end=\"1436\"\u003e\u003cstrong data-start=\"1324\" data-end=\"1336\"\u003eFormato:\u003c\/strong\u003e PDF professionale\u003cbr data-start=\"1354\" data-end=\"1357\"\u003e\u003cstrong data-start=\"1357\" data-end=\"1371\"\u003ePagine:\u003c\/strong\u003e 149 pagine\u003cbr data-start=\"1382\" data-end=\"1385\"\u003e\u003cstrong data-start=\"1385\" data-end=\"1403\"\u003eAggiornata a:\u003c\/strong\u003e Gennaio 2026\u003cbr data-start=\"1416\" data-end=\"1419\"\u003e\u003cstrong data-start=\"1419\" data-end=\"1430\"\u003eLingue:\u003c\/strong\u003e ITA - ENG\u003c\/p\u003e\n\u003cp data-start=\"4025\" data-end=\"4130\"\u003e\u003cstrong\u003eSCARICA UNA PREVIEW DELLA GUIDA\u003c\/strong\u003e\u003c\/p\u003e\n\u003ctable style=\"width: 54.1%; border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-yfti-tbllook: 1184; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt;\" width=\"54%\" cellpadding=\"0\" 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style=\"margin-bottom: 8pt; line-height: 115%; text-align: center;\" class=\"MsoNormal\"\u003e\u003cb\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Operational_Guide_to_the_Implementation_of_EU_GMP_Annex_1_ENG_PREVIEW.pdf?v=1767025526\" rel=\"noopener\" target=\"_blank\"\u003ePreview ENG\u003c\/a\u003e\u003ca rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Operational_Guide_to_GMP_Cleaning_Validation_ENG_PREVIEW.pdf?v=1766920760\" target=\"_blank\"\u003e \u003c\/a\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/ALCOA_operational_Guide_to_Data_Integrity_ENG_PREVIEW.pdf?v=1764867387\" title=\"ALCOA+ \u0026amp; Data Governance – La Guida Operativa Definitiva per la Data Integrity Pharma\" rel=\"noopener\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e","brand":"GuideGxP","offers":[{"title":"ENG - English","offer_id":53674027843914,"sku":null,"price":129.0,"currency_code":"EUR","in_stock":true},{"title":"ITA- Italiano","offer_id":53674027876682,"sku":null,"price":129.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Guide_ANNEX_1_GMP_COVER_a44ca331-2812-41e9-b4e9-e8accb2d7ace.png?v=1767027283"},{"product_id":"contamination-control-strategy-ccs-guida-operativa-annex-1-eu-gmp","title":"Contamination Control Strategy (CCS) – Guida Operativa Annex 1 EU GMP","description":"\u003cp data-end=\"487\" data-start=\"255\"\u003eLa \u003cstrong data-end=\"298\" data-start=\"258\"\u003eContamination Control Strategy (CCS)\u003c\/strong\u003e è un requisito centrale dell’\u003cstrong data-end=\"358\" data-start=\"328\"\u003eAnnex 1 EU GMP (Rev. 2022)\u003c\/strong\u003e e rappresenta il cuore del nuovo approccio \u003cstrong data-end=\"427\" data-start=\"402\"\u003eolistico e risk-based\u003c\/strong\u003e al controllo della contaminazione nella produzione sterile.\u003c\/p\u003e\n\u003cp data-end=\"692\" data-start=\"489\"\u003eQuesta guida operativa supporta la \u003cstrong data-end=\"577\" data-start=\"524\"\u003ecostruzione e l’implementazione pratica della CCS\u003c\/strong\u003e, trasformando i requisiti normativi in \u003cstrong data-end=\"669\" data-start=\"617\"\u003edocumentazione audit-ready e strumenti operativi\u003c\/strong\u003e integrati nel \u003cstrong data-end=\"691\" data-start=\"684\"\u003ePQS\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch2 data-end=\"727\" data-start=\"699\"\u003eCosa troverai nella guida\u003c\/h2\u003e\n\u003cp data-end=\"806\" data-start=\"729\"\u003eLa guida fornisce un approccio concreto e applicabile alla CCS, con focus su:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli data-end=\"859\" data-start=\"810\"\u003estruttura e contenuti CCS secondo Annex 1\u003c\/li\u003e\n\u003cli data-end=\"917\" data-start=\"862\"\u003eintegrazione con \u003cstrong data-end=\"915\" data-start=\"879\"\u003eQuality Risk Management (ICH Q9)\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"982\" data-start=\"920\"\u003ecollegamento con \u003cstrong data-end=\"980\" data-start=\"937\"\u003ePharmaceutical Quality System (ICH Q10)\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003cli data-end=\"1071\" data-start=\"985\"\u003eelementi chiave: locali, attrezzature, personale, utilities, materiali e monitoraggi\u003c\/li\u003e\n\u003cli data-end=\"1120\" data-start=\"1074\"\u003eutilizzo della CCS durante audit e ispezioni\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-end=\"1161\" data-start=\"1127\"\u003eChecklist e strumenti operativi\u003c\/h2\u003e\n\u003cp data-end=\"1176\" data-start=\"1163\"\u003eSono inclusi:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli data-end=\"1207\" data-start=\"1179\"\u003echecklist di CCS readiness\u003c\/li\u003e\n\u003cli data-end=\"1256\" data-start=\"1210\"\u003eindicazioni sui principali finding ispettivi\u003c\/li\u003e\n\u003cli data-end=\"1326\" data-start=\"1259\"\u003etemplate di supporto (risk assessment, gap analysis, struttura CCS)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 data-end=\"1353\" data-start=\"1333\"\u003eA chi è destinata\u003c\/h2\u003e\n\u003cp data-end=\"1435\" data-start=\"1355\"\u003eQA, Produzione Sterile, Microbiologia, Validation, Engineering, QP e Management.\u003c\/p\u003e\n\u003ch2 data-end=\"1466\" data-start=\"1442\"\u003eDettagli del prodotto\u003c\/h2\u003e\n\u003cp data-start=\"1324\" data-end=\"1436\"\u003e\u003cstrong data-start=\"1324\" data-end=\"1336\"\u003eFormato:\u003c\/strong\u003e PDF professionale\u003cbr data-start=\"1354\" data-end=\"1357\"\u003e\u003cstrong data-start=\"1357\" data-end=\"1371\"\u003ePagine:\u003c\/strong\u003e 61 pagine\u003cbr data-start=\"1382\" data-end=\"1385\"\u003e\u003cstrong data-start=\"1385\" data-end=\"1403\"\u003eAggiornata a:\u003c\/strong\u003e Gennaio 2026\u003cbr data-start=\"1416\" data-end=\"1419\"\u003e\u003cstrong data-start=\"1419\" data-end=\"1430\"\u003eLingue:\u003c\/strong\u003e ITA - ENG\u003c\/p\u003e\n\u003cp data-start=\"4025\" data-end=\"4130\"\u003e\u003cstrong\u003eSCARICA UNA PREVIEW DELLA GUIDA\u003c\/strong\u003e\u003c\/p\u003e\n\u003ctable style=\"width: 54.1%; border-collapse: collapse; border: none; mso-border-alt: solid windowtext .5pt; mso-yfti-tbllook: 1184; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt;\" width=\"54%\" cellpadding=\"0\" cellspacing=\"0\" border=\"1\" class=\"MsoTableGrid\"\u003e\n\u003ctbody\u003e\n\u003ctr style=\"mso-yfti-irow: 0; mso-yfti-firstrow: yes; mso-yfti-lastrow: yes;\"\u003e\n\u003ctd style=\"width: 48.2%; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"48%\"\u003e\n\u003cp style=\"margin-bottom: 8pt; line-height: 115%; text-align: center;\" class=\"MsoNormal\"\u003e\u003ca rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Contamination_Control_Strategy_CCS_Guida_ANNEX_1_ITA_PREVIEW.pdf?v=1767026305\" target=\"_blank\"\u003e\u003cb\u003ePreview ITA \u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003ctd style=\"width: 50.9%; border: solid windowtext 1.0pt; border-left: none; mso-border-left-alt: solid windowtext .5pt; mso-border-alt: solid windowtext .5pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\" width=\"50%\"\u003e\n\u003cp style=\"margin-bottom: 8pt; line-height: 115%; text-align: center;\" class=\"MsoNormal\"\u003e\u003cb\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Operational_Guide_to_the_Implementation_of_EU_GMP_Annex_1_ENG_PREVIEW.pdf?v=1767025526\" rel=\"noopener\" target=\"_blank\"\u003e\u003c\/a\u003e\u003ca rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Contamination_Control_Strategy_CCS_ANNEX_1_Guide_ENG_PREVIEW.pdf?v=1767026268\" target=\"_blank\"\u003ePreview ENG\u003c\/a\u003e\u003ca rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Operational_Guide_to_GMP_Cleaning_Validation_ENG_PREVIEW.pdf?v=1766920760\" target=\"_blank\"\u003e \u003c\/a\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/ALCOA_operational_Guide_to_Data_Integrity_ENG_PREVIEW.pdf?v=1764867387\" title=\"ALCOA+ \u0026amp; Data Governance – La Guida Operativa Definitiva per la Data Integrity Pharma\" rel=\"noopener\" target=\"_blank\"\u003e\u003c\/a\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e","brand":"GuideGxP","offers":[{"title":"ENG - English","offer_id":53674086236490,"sku":null,"price":129.0,"currency_code":"EUR","in_stock":true},{"title":"ITA- Italiano","offer_id":53674086269258,"sku":null,"price":129.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/CCS_contamination_control_strategy_ANNEX_1_GMP_COVER.png?v=1767025930"},{"product_id":"aseptic-process-simulation-media-fill-guida-pratica-secondo-annex-1-eu-gmp","title":"Aseptic Process Simulation (Media Fill) – Guida Pratica secondo Annex 1 EU GMP","description":"\u003cp data-start=\"236\" data-end=\"448\"\u003eL’\u003cstrong data-start=\"238\" data-end=\"274\"\u003eAseptic Process Simulation (APS)\u003c\/strong\u003e, o \u003cem data-start=\"278\" data-end=\"290\"\u003eMedia Fill\u003c\/em\u003e, è un requisito chiave dell’\u003cstrong data-start=\"319\" data-end=\"349\"\u003eAnnex 1 EU GMP (Rev. 2022)\u003c\/strong\u003e per dimostrare l’efficacia dei processi asettici e della \u003cstrong data-start=\"407\" data-end=\"447\"\u003eContamination Control Strategy (CCS)\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"450\" data-end=\"623\"\u003eQuesta guida pratica supporta la \u003cstrong data-start=\"483\" data-end=\"533\"\u003eprogettazione, esecuzione e gestione degli APS\u003c\/strong\u003e, traducendo i requisiti normativi in \u003cstrong data-start=\"571\" data-end=\"622\"\u003eattività operative e documentazione audit-ready\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch2 data-start=\"630\" data-end=\"658\"\u003eCosa troverai nella guida\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli data-start=\"662\" data-end=\"711\"\u003erequisiti APS secondo Annex 1, FDA, PIC\/S e WHO\u003c\/li\u003e\n\u003cli data-start=\"714\" data-end=\"784\"\u003eprogettazione dello studio (worst-case, durata, formati, interventi)\u003c\/li\u003e\n\u003cli data-start=\"787\" data-end=\"842\"\u003eintegrazione con \u003cstrong data-start=\"804\" data-end=\"820\"\u003eQRM (ICH 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