GMP News - Pharmaceutical Technology

In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.

The long-awaited draft of the new Annex 1 was published in December 2017. Besides mainly contents concerning sterile production, it also contains various updates on the manufacturing and distribution of water to be used in pharmaceutical production.

The guideline VDI 6022 Part 1 underwent substantial revisions and now contains many new obligations for manufacturers, planners, constructors, operators and supervisors of HVAC systems and air conditioners.

In January, the VDI published a completely revised edition of part 1 of the VDI 6022 series. The guideline deals with hygiene for HVAC systems with the objective of preventing negative effects on room air.

In December, the Swissmedic - the Swiss Agency for Therapeutic Products, has published a short statement on how to handle differences between different GMP guidelines.

After many postponements, the long awaited Annex 1 draft of the EU GMP Guideline has finally been published on 20 December, 2017. While the chapters on integrity testing and visual inspection of injectables used to be rather short, the draft now contains several updates.

The company Celltrion in South Korea received a so-called Form 483 report as a result of an inspection of the facility in May and June 2017. Amongst other things, it criticised particle findings in released products, insufficient environmental monitoring and deficiencies in aseptic activities. Read more about the deficiencies found during the inspection.