GMP News

Due to fundamental GMP deficiencies, the FDA has issued a Warning letter to a US manufacturer of homeopathic drugs. Read more here.

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site. 

The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).

With the Mutual Recognition Agreement between Europe and the USA, inspections are to be mutually recognised in the future. The FDA's approval of the EU Member States proceeds successively. Two more countries have recently been approved.

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 3: What agreements need to be included in contracts with cloud service providers in order to ensure data integrity?

The US Food & Drug Administration (FDA) has recently issued a new draft guidance on the initiation of voluntary recalls.

The FDA has recently issued another Warning Letter to an US pharmaceutical manufacturer describing serious GMP deficiencies. This concerns among others the water system, the QC laboratory and quality assurance.

The US FDA published its regular inspection report on Human Cell, Tissue and Cell based Products (HCT/Ps), which also includes current data from 2018.

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.

In March, the American authority FDA issued a Warning Letter to a US pharmaceutical manufacturer due to numerous violations of GMP. Among other things, inadequate cleaning of the equipment, errors in the stability studies as well as in contamination control were found.

There is currently a growing interest in the development of therapies derived from cannabis and its components.The FDA recently announced to form an internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD.

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