Guideline Knowledge Base
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Available Guidelines
209 matches
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The complete set of annexes to the PIC/S GMP Guide (PE 009), including Annex 1 (sterile products), Annex 11 (computerised systems), Annex 15 (qualification and validation), Annex 19 (reference and retention samples) and Annex 20 (quality risk management). Harmonised with the EudraLex Volume 4 annexes.
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Part II of the PIC/S GMP Guide (PE 009): basic requirements for active substances used as starting materials. Harmonised with EudraLex Volume 4 Part II / ICH Q7.
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Part I of the PIC/S GMP Guide (PE 009): basic requirements for medicinal products, covering the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls, and self-inspection. Harmonised with EudraLex Volume 4 Part I.
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Introduction to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009). The PIC/S GMP Guide is harmonised with EudraLex Volume 4 and is the inspection standard applied by PIC/S participating authorities.
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Imported from European Commission — EudraLex (https://health.ec.europa.eu/latest-updates/commission-staff-working-document-use-titanium-dioxide-medicinal-products-2025-08-06_en).
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Imported from European Commission — EudraLex (https://health.ec.europa.eu/latest-updates/document-summarising-evidence-supporting-legislative-proposal-strengthening-availability-supply-and-2025-09-03_en).
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Imported from European Commission — EudraLex (https://health.ec.europa.eu/latest-updates/new-and-updated-documents-eudralex-volume-10-clinical-trials-guidelines-2025-10-30_en).
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Imported from European Commission — EudraLex (https://health.ec.europa.eu/latest-updates/new-and-updated-documents-eudralex-volume-10-clinical-trials-guidelines-2025-10-30_en).
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Imported from European Commission — EudraLex (https://health.ec.europa.eu/latest-updates/new-and-updated-documents-eudralex-volume-10-clinical-trials-guidelines-2025-10-30_en).
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Imported from European Commission — EudraLex (https://health.ec.europa.eu/latest-updates/new-and-updated-documents-eudralex-volume-10-clinical-trials-guidelines-2025-10-30_en).
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