New Inspection Guideline for GMP Labs

GMP News No. 657

GMP News
2 January 2006

New Inspection Guideline for GMP Labs

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:

  • Quality Management System (e.g. change control, self-inspection)
  • Documentation (SOPs, lab notebooks, etc.)
  • Personnel
  • Equipment (qualification and calibration)
  • Materials (among others reference standards)
  • Analytical samples and sampling
  • Testing
  • Stability testing
  • Validation of analytical methods
  • System for OOS investigations

The complete document can be found here.

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
This course gives a detailed and practice-oriented overview of the calibration and qualification of analytical equipment in pharmaceutical quality control. One of the subjects is the future USP Monograph <1058> "Analytical Instrument Qualification".

ECA Education Course Out-of-Specification Results, 27-28 March 2006, Vienna
Recent developments emerging from the PDA Working Party Draft Guidance on OOS Results and FDA will be presented and discussed. The OOS Education Course is followed by a Post-Course Workshop on Failure Investigation, 29 March 2006, Vienna, for QC and QA professionals.

Dr Günter Brendelberger
on behalf of ECA

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