GMP News - Aseptic / Microbiology

Will the revised Annex 1 provide guidance for the application of GMP to sterile primary packaging materials?

On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.

The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.

The International Council for Harmonistion (ICH) finalized their recommendation relating to the use of the pharmacopoeial texts on tests for specified microorganisms.

The International Council for Harmonisation ICH Q4B - Harmonisation of pharmacopoeial chapters on Sterility Test with step 5 has now been finalized.

In July the FDA published the revised version of BAM: Bacteriological Analytical Manual Chapter 23 Microbiological Methods for Cosmetics.

The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?