GMP News - Quality Assurance

Due to the deficiencies discovered during an inspection performed in July 2018, the US FDA has now issued a Warning Letter to a US pharmaceutical manufacturer of homeopathic drug products. Microbiological impurities in the products and the water used to manufacture the medicinal products are an essential aspect of the complaint.

The BfArM has awarded the first contracts for the cultivation of medicinal Cannabis in Germany to two manufacturers. This means that the cultivation of pharmaceutical quality Cannabis in Germany can now commence.

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to the review of the batch documentation?

The Office of Pharmaceutical Quality (OPQ) was established in 2015 within the FDA as part of the Center for Drug Evaluation and Research (CDER). The aim was to ensure the quality of medicinal products throughout their entire lifecycle, from development to commercialisation. Now, the FDA's OPQ has reviewed the year 2018 and published a 13-page report.

Regulations require that the critical process variables should be included in validation. This has been recently confirmed again by the FDA in a Warning Letter.

In the current issue of the Pharmacopeial Forum, the USP general chapters on plastic packaging materials have been re-published for comment.

The FDA provided additional guidance on risk-based monitoring for effective oversight, including Data Integrity. Read more on FDA`s draft Guidance for Industry A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.