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
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.
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.
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.
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.
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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