GMP NEWS 2020

The World Health Organization (WHO) has published a draft proposal for revision in The International Pharmacopoeia. The document entitled DISSOLUTION TEST FOR SOLID ORAL DOSAGE FORMS will be posted on the WHO Medicines website. The deadline for comments is 31 August 2020.

The topic data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 9: Must data flow diagrams be available?

The drafts for the new Ph. Eur. chapters on plastic packaging materials (COP, COC, and Extractable elements in plastic materials for pharmaceutical use) have been re-published in Pharmeuropa to give stakeholders sufficient time to comment.

A FDA draft guideline entitled "Review and Update of Device Establishment Inspection Process and Standards" on FDA inspections of medical device manufacturers has now been finalized.

The European Commission, the HMA and the EMA released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling.

The FDA issued a Warning Letter to a manufacturer of aseptic homeopathics in Canada after the deficiencies listed in a 483 letter sent last October were not satisfactorily addressed.

The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.

Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.

The Q&A document on variations entitled "Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008" of the CMDh and CMDv was updated again in May 2020.