Richtlijnen Kennisbank
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Beschikbare richtlijnen
108 resultaten
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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 Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/compilation-union-procedures-inspections-exchange-information).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/joint-audit-programme).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation).
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Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/joint-audit-programme).
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Sets the criteria under which the FDA considers electronic records, electronic signatures and handwritten signatures executed to electronic records to be trustworthy, reliable and equivalent to paper records. Covers controls for closed and open systems, signature manifestations and record linking, and electronic signature components, controls and identification codes.
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The FDA's core CGMP regulation for finished pharmaceuticals, covering organisation and personnel, buildings and facilities, equipment, control of components, production and process controls, packaging and labelling, holding and distribution, laboratory controls, records and reports, and returned and salvaged drug products. Amended by 89 FR 51769 (18 June 2024, effective 18 December 2025) to exclude medical gases.
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