New WHO Draft on the Manufacture of Sterile Medicinal Products

With the revision of the WHO Technical Report Series (TRS) No. 957 in June 2010, the WHO also published a new draft for a revised Annex 4 "Good manufacturing practices for sterile pharmaceutical products". The complete report of the 44th WHO Expert Committee on Specifications for Pharmaceutical Preparations is also available as a WHO publication on the WHO website.

The former WHO requirements on GMP for sterile medicinal products date back to 2002 and were published in the document TRS 9002 Annex 6. Due to recent technological and regulatory developments, a revision became necessary. In essence, the new draft has now been harmonised with current international regulations, e. g. with

  • US FDA Guidance for industry - Sterile drug products produced by aseptic processing
  • EU GMP guideline - Annex 1
  • Japan Guidance for industry - Sterile drug products produced by aseptic processing
  • ISO 14644

The structure of the draft document, which strongly follows the EU GMP Guideline - Annex 1, has been maintained. New additions are chapters on Blow Fill Seal (BFS) and isolators. The chapter "Finishing of sterile products" was extended by adding new requirements on capping (see News of 13 January 2010) and the chapter "Manufacture of sterile preparations" was also adapted to ISO 14644.

Special emphasis is placed on the fact that these new requirements, part of which imply considerable investments (e. g. the requirements on capping), can only be implemented step by step in the pharmaceutical industry.

Andreas Mangel
On behalf of the European Compliance Academy (ECA)

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