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 Austrian competent authority has published a Statement of Non-Compliance with GMP to an Austrian manufacturer after a distance assessment. The Manufacturing Authorisation was now revoked.
The European Pharmacopoeia (Ph. Eur.) has published the revised chapter 2.2.48 on Raman Spectroscopy for public consultation. All interested users are encouraged to review the draft and submit their comments from July to September 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.
Emer Cooke from Ireland will be the new director of the European Medicines Agency (EMA) in Amsterdam. This was announced by the EMA Management Board.
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 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.
Due to the Covid-19 pandemic, the EU had decided to postpone the date of application of the Medical Devices Regulation by one year to 26 May 2021. What consequences does this have for the industry?
The CMDh and CMDv recently published a revised version of the Q&A paper regarding variations including a new question on how to notify about an update of the QPPVs contact details.
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.