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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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Recommendations on VMP, Installation and Operational Qualification, Process Validation, Cleaning Validation
Gepubliceerd enThis document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: the Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation by PIC/S.
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This Annex deals with the manufacture of active substance gases and with the manufacture of medicinal gases.
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