PIC/S

EU and EMA | GMPs | PIC/S

White Paper – Prevention of Contamination and Cross-Contamination in Medicinal Manufacturing Facilities
ByPharmOut 05-May-201403-Oct-2022

This White Paper explores the methods of preventing contamination and cross-contamination in manufacturing facilities. Purpose To identify potential contributors of contamination and cross contamination. To offer ideas on how to minimise and prevent contamination and cross contamination occurring within a manufacturing facility. Audience Project Managers Validation professionals QA professionals Prerequisites Familiarity with Annex 15 Qualification…

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GMPs | PIC/S | Qualification & Validation

White Paper – Top 10 considerations when validating an autoclave
ByPharmOut 10-Apr-201403-Oct-2022

Validating an autoclave Purpose Validating an autoclave is a daunting and time-consuming task. This white paper details the tricks, tips and traps to such a validation project from how to choose your control to which load configuration to use for your validation runs. The white paper presents very practical steps to validate an autoclave by…

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GMPs | PIC/S

New 2016 GMP Quiz
ByPharmOut 18-Mar-201403-Oct-2022

A New Year a New GMP quiz! You’ve probably already done the old quiz, so test your updated GMP knowledge with the latest PharmOut 2016 GMP quiz. All new questions have been developed as well and a handy little hint is available for those who keep a copy of the PIC/S guide handy. Feeling like a…

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GMPs | PIC/S

New Revision of PIC/S GMP Guides (PE 009-11)
ByPharmOut 04-Feb-201403-Oct-2022

March 1st 2014 will see the newest revision of the PIC/S GMP Guide (PE 009-11) come into effect, replacing the previous version PE 009-10 that has been current since January 2013.

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PIC/S

Update from PIC/S Meeting in Geneva
ByPharmOut 22-Jun-201303-Oct-2022

The PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Sub-Committee on Training Meeting took place in Geneva between 28-30 May 2013. The main topics that were discussed are summarized below. A new Sub-Committee structure of PIC/S will enter into force on 1 January 2014. It foresees a more participative and efficient organisation where each…

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GMPs | PIC/S | TGA

History of TGA Proposal for Automatic Adoption of New Versions of the PIC/S Guide to GMP
ByPharmOut 31-May-201303-Oct-2022

TGA adoption of PIC/S GMP Guide for Medicinal Products Which version of the PIC/S GMP Guide does the TGA refer to? PIC/S Version 14, PIC/S Version 15, or PIC/S Version 16? PIC/S GMP Guide PE 009-15 (PIC/S Version 15) was published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in May 2021. This version (Version 15)…

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PIC/S | QRM

Useful Tips for Quality Risk Management Implementation
ByPharmOut 25-Feb-201303-Oct-2022

On 29 July 2009, Australia’s Therapeutic Goods Administration (TGA) adopted the PIC/S Guide to Good Manufacturing Practice PE009-8. One of the single biggest changes from the previous Australian Code of Good Manufacturing Practice was, and remains, the codification of Quality Risk Management (QRM). The industry was unprepared for the impact of QRM and, although the…

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GMPs | PIC/S

Just issued – New PIC/S code Good Manufacturing Practice – effective 1st January 2013
ByTrevor 19-Dec-201206-Jul-2023

The PIC/S meeting in Kiev discussed and agreed on changes to PE009-9 to support the harmonisation of GMP guidance documents. PIC/S code of GMP PE-009-10 was issued by PIC/S on the 11th December, and whilst this goes some way in aligning our international GMPs and specifically the EMEA code of GMP, there are still significant…

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