Guide to Microbiology Laboratories in the Pharmaceutical Industry

General Introduction

Quality Control Laboratories may perform some or all quality control activities e.g. sampling, testing of raw materials, testing of intermediate, testing of finished products, testing of packaging materials stability testing and investigative testing. Microbiology laboratories may be part of a production facility producing sterile products, non-sterile products, API’s or raw materials and involved in all the activities associated with demonstrating compliance of those materials. Microbiology laboratories may also be contract testing laboratories performing testing of such products/materials on behalf of other companies.

This guide details best practice for microbiology laboratories associated with all aspects of supporting the manufacture of medicinal products. These guidelines are applicable to any pharmaceutical microbiology testing laboratory and supplements already existing regulations and guidance documents by providing additional specific detail on current practices and recent regulatory expectations.

Some existing regulations and guidance are detailed here. 

• 21 CFR Part211. Subpart I
• Eudralex Volume 4 Chapter 6
• WHO  Technical Report No 957 Annex 1WHO Good Practices for pharmaceutical Quality Control Laboratories
• FDA Inspection Guide - Microbiological Pharmaceutical Quality control of Laboratories (7/93)
• USP Microbiological Best Laboratory Practices
• FDA Guidance for Industry (Sterile drug Products Produced by Aseptic Processing – Current Good Manufacturing Process)
• PIC/S Inspection of Pharmaceutical Quality Control Laboratories December 2005

Guide to Microbiology Laboratories in the Pharmaceutical Industry