GMP NEWS 2020

Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.

The term Design Qualification is not used in the current FDA Guidance on Process Validation. However, it is addressed that the design of a facility plays a role within the scope of a qualification. Moreover, in a current Warning Letter the FDA criticizes design deficiencies in a water system.

When complying with the requirements of the Anti-Counterfeiting Directive, the status message "recall" for recalled batches is of great relevance for the entire supply chain. What has to be considered here?

The British MHRA has joined an Australia-Canada-Singapore-Switzerlan Consortium to explore opportunities for information and work-sharing.

A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.

A US-American pharmaceutical manufacturer has recently received a Warning Letter from the FDA due to deficiencies in packaging and quality assurance.

In September the ECA offered the first Cleaning Validation Online Training Course - with many questions for the speaker. The ECA would like to share a selection of these Q&As on Cleaning Validation with the community.

Medical devices are essential medical tools and that is why health authorities are also interested in their development. For this purpose, the FDA has presented a catalog of tools for the development of medical devices.

A successfully completed process validation is one of the basic GMP requirements for a product to be marketed. So, how does an authority react if a product is already on the market but no process validation has been carried out? The FDA provides answers in a current Warning Letter.