You Are Not Sign In
Customer SignInCustomer Account
Language
2/23/2015
A RECOMMENDED MODEL FOR RISK-BASED INSPECTION PLANNING IN THE GMP ENVIRONMENT
The purpose of this PIC/S Recommendation is to provide a simple and qualitative Quality Risk Management tool that may be of use to Inspectorates to prioritize sites for inspection when planning the frequency and scope of GMP Inspections.
2/23/2015
ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING
ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING
2/23/2015
STERILITY TESTING
The purpose of this document is to provide guidance for GMP inspectors to use for training purposes and in preparation for inspections in order to promote a consistent and thorough approach in all aspects of sterility testing
2/23/2015
GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENTS
The PIC/S Guide to Good Manufacturing Practices is the basis for GMP inspections. In particular its Annex 11, ‘Computerised Systems’ is used when inspecting such systems.
2/23/2015
PIC/S GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS AND PLASMA WAREHOUSES (INSPECTION GUIDE)
The purpose of this document is to provide guidance for GMP inspectors in preparation for inspections and conduct of inspections of source plasma establishments and / or plasma warehouses as well as for training purposes. For inspections of blood establishments, collecting and processing full blood donations by segregation into red blood cells, plasma and other components, reference is made to the PIC/S GMP Guide for Blood Establishments (PE 005).
2/23/2015
VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION
The topics of these Recommendation documents reflect some of the areas in pharmaceutical manufacture identified by both Inspectorates and the Pharmaceutical Industry as requiring guidance additional to that given in the current PIC/S GMP Guide.
2/23/2015
GUIDANCE ON PARAMETRIC RELEASE
The purpose of the document is to provide guidance for GMP inspectors to use for training purposes and in preparation for inspections of company premises where Parametric Release has been approved or applied for. In addition the document provides a framework for GMP inspectors and Marketing Authorisation assessors to work together and jointly approve an application for Parametric Release.
2/23/2015
VALIDATION OF ASEPTIC PROCESSES
The aim of this document is to provide guidance to the current practice in this field by giving recommendations for the validation of aseptic processes. In particular, the document should provide guidance for GMP inspectors both for training purposes and in preparation for inspections of company premises.
2/23/2015
PIC/S GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS
This Guide is based on the EU Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use (2013/C 343/01). The EU Guidelines have been adapted by the Expert Circle on GDP for PIC/S purposes. However, the EU specific references have been deleted in this Guide.
2/23/2015
PIC/S GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS
The purpose of this Guide is to provide guidance on Good Practices on the preparation of medicinal products for human use.
Displaying results 1-10 (of 11)
 |<  < 1 - 2  >  >|