GMP News - Quality Assurance

The U.S. Food and Drug Administration (FDA) has published a Warning Letter sent to a drug manufacturer in Massachusetts, USA. Since the deficiencies found even concern simple GMP basic requirements, the company had to stop production and distribution in the meantime. What is actually interesting is that the FDA, among other things, explicitly criticizes the lack of a humidity control in the warehouse.

Due to numerous and fundamental GMP deficiencies, the FDA has issued a Warning Letter to a manufacturer of over-the-counter antibacterial hand soap, antiseptics and hand sanitizer in Puerto Rico.

On August 01, 2023, the new USP Chapter "<1083> Supplier Qualification" will officially enter into force. In the USP Forum, the draft chapter could be viewed and commented on until the end of November 2021.

Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.

A Slovakian company has its GMP certificate withdrawn after an inspection. The Qualified Person (QP) was also mentioned.

Two sampling techniques are generally used in cleaning validation. The rinse test and the swab test. The following are notes on potential issues with the swab test.

The Danish Medicines Agency has prepared a new guidance for the pilot programme on cannabis products. Amongst others, the document contains GMP and other quality requirements for Danish-made cannabis products.