GMP News

Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.

The recently published final assessment report of the CHMP describes in great detail the state of knowledge on nitrosamines in human medicinal products. All you need to know about risk assessment, calculation of limit values and analysis of nitrosamine contamination can be found in this document.

The European Medicines Agency (EMA) has published the final version of its guideline on the use of the different pharmaceutical water qualities. The revision had become necessary due to the possibility to produce WFI using methods other than distillation. Read more here.

The FDA offers diverse online material as part of their CDERLearn Training and Education Program. A special section contains courses for the pharmaceutical industry.

In July, new topics were added to the question and answer catalogue "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC".

In this Warning Letter from the FDA to a manufacturer of unauthorised tissue-based products, deficiencies in current Good Tissue Practice (cGTP) and violations of fundamental GMP regulations are described. 

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.