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Strategy – An Overview Contamination Control
Aseptic processing controls Minimization microbiological, pyrogen and particulate contamination BFS machine design and operational controls Control of lyophilization processes Environmental and process monitoring programs Approach to managing hazardous materials. Risk based requirements for identification of organisms Strategy for starting ...
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<790> VISIBLE PARTICULATES IN INJECTIONS - PharmOut
www.pharmout.netGeneral Chapters General Information Add the following: á1044ñ CRYOPRESERVATION OF CELLS INTRODUCTION Cryopreservation is the process of cooling and storing cells, tissues, or organs at very low temperatures to maintain their
Facility Qualification - PharmOut
www.pharmout.netSlide 7 © PharmOut 2013 Planning for Facility Qualification Design Qualification Requirements Concept Design Design Drawings & Specs Design
The 10 Golden Rules of GMP - PharmOut
www.pharmout.netPharmOut white paper: The 10 Golden Rules of GMP PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151.
Top 10 considerations when validating an autoclave
www.pharmout.netPharmOut white paper: Top 10 considerations when validating an autoclave PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151.
PIC/S GMP Guide – Annex 1 Revisions & Interpretations
www.pharmout.netThe Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently introduced updated versions of both their GMP guide and the associated annexes, which deal with a variety of different specific
How to implement Good Documentation Practices - PharmOut
www.pharmout.netPharmOut white paper: How to implement Good Documentation Practices PharmOut Pty Ltd, ABN: 85 117 673 766, Unit 10, 24 Lakeside Drive, Burwood East, Victoria 3151.
BRIEFING - PharmOut
www.pharmout.netBRIEFING 〈1790〉 Visual Inspection of Injections. The General Chapters—Dosage Forms Expert Committee proposes this new chapter to provide guidance …
Restricted Access Barrier Systems & Isolators
www.pharmout.netSlide 2 © PharmOut 2017 Learning objectives We will Learn • What isolators are and why they were developed • The difference between a RABS and an isolator
EU GMP Guide-Annex 15 Qualification & Validation draft ...
www.pharmout.netEU GMP Guide-Annex 15 Qualification & Validation draft released In February 2014, a draft of the revised Annex 15 was released by the European Commission (EC) for public comment. The draft version is based on an EMA Concept Paper, published in November 2012 which outlined various reasons for the revision of Annex 15.
Prevention of Contamination and Cross-Contamination in ...
www.pharmout.net©2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. ... have adequate space for placement of equipment as well as production and packaging materials ... before commencing manufacture of a subsequent batch Document the cleaning status of each equipment in logbooks General housekeeping
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