Direkt-Links zu wichtigen GMP Guidelines

PIC/S Explanatory Note for Industry on the Preparation of a Site Master File (PE 008-4) Jan 2011

Detaillierte Anleitung zur Erstellung einer Firmenbeschreibung (Site Master File)

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PIC/S Validation of Aseptic Processing (PI 007-6) 2011

Detaillierte Empfehlungen zur Validierung des aseptischen Prozesses auf verschiedene Darreichungsformen bezogen, einschließlich statistischer Grenzwerte. Dokument referenziert auf ISO 13408-1

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PIC/S Recommendations on Sterility Testing (PI 0012-3) Sept 2007

Guidelines für GMP-Inspektoren, um eine einheitliche Vorgehensweise bei der Inspektion aller Aspekte des Steriltests zu erreichen.

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PIC/S PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

Information zu PIC/S

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PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007

This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows: Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation The four Recommendations comprising this document define general principles pertaining to each of the topics.

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PIC/S GMP Guide for Blood Establishments (PE 005-3) Sept 2007

This document applies to blood and apheresis establishments relating to the collection, preparation, storage, dispatch, quality control and quality assurance of human blood and blood components.

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PIC/S Recommendations on Quality System Requirements for Pharmaceutical Inspectorates (PI 002-3)Sept 2007

This document specifies the quality system requirements for National pharmaceutical inspection services concerned with good manufacturing practice and good wholesale distribution practice of medicinal products.

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PIC/S Isolators used for Aseptic Processing and Sterility Testing (PI 014-3) Sept 2007

This Recommendation applies to isolators subjected to a sporicidal process used for aseptic processing and sterility testing.

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PIC/S Aide-Memoire - Inspection of Utilities (PI 009-3) Sept 2007

The Aide-Memoire describes different areas which could be evaluated during the GMP inspection of HVAC systems, pharmaceutical water, steam and medicinal gases.

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PIC/S Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects (PI 010-5) July 2017

This procedure covers transmission of information by means of a Rapid Alert between the different parties relating to the recall of medicinal products which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health and animal health.

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