WHO Proposes New Guideline for Microbiology Labs and Adjustments to Site Master File, Water and HVAC Guides

WHO is expanding its guidance library to focus specifically on GMP expectations for microbiology labs and is adjusting its existing guidelines on drafting site master files, on water used in pharmaceutical manufacturing and on and heating, ventilation, and air-conditioning (HVAC) systems.

Comments on the draft documents are due to WHO by September 1 for the site master file and water guides, by September 9 for the HVAC guideline, and by October 1 for the microbiology lab document.

The new draft guideline on microbiology lab GMPs grew out of inspector experience with the 2009 revision of WHO’s “Good Practices for Pharmaceutical Quality Control Laboratories.”

WHO inspectors found that the QC labs they were prequalifying “might benefit from additional guidance, with a special focus on microbiology,” the background section of the new document explains. Their suggestions were reviewed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations resulting in development of the micro guide.

The 27-page draft guideline contains 12 sections describing micro lab good practices regarding:  • personnel •  environment •  validation of test methods •  equipment • reagents and culture media •  reference materials and reference cultures •  sampling • sample handling and identification •  disposal of contaminated waste •  quality assurance of results/quality control of performance •  testing procedures, and •  test reports.

Also included are five appendices covering the general use of reference cultures and examples of lab operations, including calibration, qualification, and maintenance of equipment.

Along with the pharmaceutical QC lab good practices, other WHO documents applicable to microbiology labs, the new guide notes, include:

• General guidelines for the establishment, maintenance and distribution of chemical reference substances

• The International Pharmacopoeia and first supplement (fourth edition), and

• General requirements for the competence of testing and calibration laboratories.

[More on the WHO revision effort on its site master file, pharmaceutical water, and HVAC guidelines and links to the documents discussed are provided for subscribers here.]