GMP NEWS 2016

In a recent blog, the MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU.

In a recent Pharmacopeial Forum two revised USP general chapters have been published for comment. With these drafts, the USP expert committee is removing the requirement for <87> Biological Reactivity Tests, In Vitro testing for packaging materials and systems for oral and topical dosage forms. Read more about the draft chapters of <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use.

The WHO is currently revising its validation guidelines and has recently published a superordinate umbrella guideline. Now, an independent chapter on qualification was published for comment.

On June 16, 2016, the US Food and Drug Administration, FDA, published a draft guidance on "Quality attribute considerations for chewable tablets". Read more about the critical quality attributes recommended for chewable tablets.

At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. Please find here an analysis of this draft.

During the development of combination products, "Human Factors Studies" have been gaining importance with regard to design and development. After the FDA had received many requests on how to perform such studies, a new Draft Guidance on Human Factors Studies in Combination Product Design and Development has been elaborated.

The FDA has published a supplementing Guide on Quality Metrics. This is a very unusual step as the contents of the guide are planned to be integrated into the Guideline on Quality Metrics which hasn't been finalised yet. Read more about the Technical Quality Metrics Guide.

Asia has been in the centre of attention when it comes to GMP non-compliance. This time the company KO DA Pharmaceuticals Co has been inspected by FDA and received a Warning Letter. Read more about the FDA Warning Letter here.

Again, the company Orifarm must recall batches because of suspicion of falsification. The company located in Leverkusen, Germany has received information from the Greek Competent Authority according to which falsified blisters emerged. Read more about the current case of counterfeits.