New Inspection Guideline for GMP Labs
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GMP News No. 657
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GMP News 2 January 2006 |
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New Inspection Guideline for GMP Labs |
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On 1 January 2006, the PIC/S Aide-Memoire PI 023-1 titled Inspection of Pharmaceutical Quality Control Laboratories came into force. This document is intended for the training of GMP inspectors and for inspection preparation. The Aide-Memoire consists of a checklist with general questions (8 pages) as well as two shorter, more specific checklists for physical/chemical laboratories (2 pages) and for microbiological laboratories (3 pages). The questions in these checklists regard among others the following topics:
The complete document can be found here. |
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Two of these key compliance issues are dealt with in detail at the
following two Education Courses offered by the European Compliance
Academy:
ECA Education Course Lab Equipment
Qualification, 15.-17. February 2006, Vienna ECA Education Course Out-of-Specification
Results, 27-28 March 2006, Vienna |
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GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity