GMP News

In order to be able to continue to provide the population with high-quality, effective and safe medicinal products during the Covid-19 pandemic, Europe is taking exceptional measures. A Q&A document has been prepared in cooperation between the European Commission, the Coordination Group on Mutually Recognised and Decentralised Procedures (CMDh), the Inspectors Working Group and the European Medicines Agency (EMA). At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites".

With the publication of six final guidelines on gene therapies and one additional draft guideline, the FDA is further expanding its activities in the area of advanced therapies.

Is there a specific FDA requirement for a Design Qualification? The answer is (actually) No.

The classification defines, among other points, which kind of GMP certification is needed for export / import of Cannabis Flower to the EU and Germany.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) in the MHRA Inspectorate Blog.

On 10 April 2020, the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC) published a first version of the document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which is continuously updated and adapted.

Three drafts for new Ph. Eur. chapters on plastic packaging materials have been published for comment in the recent issue of Pharmeuropa: Cyclo-olefin polymers (COP), Cyclo-olefin copolymers (COC), and Extractable elements in plastic materials for pharmaceutical use.

The International Medical Device Regulators Forum (IMDRF) is the succeeding organisation of the Global Harmonisation Task Force (GHTF) in the field of medical devices. The aim of the group is to issue harmonised guidelines. The latest is a guidance document on "Principles and Practices for Medical Device Cybersecurity" from March 2020.

The EMA recently published a notice to sponsors which clarifies the responsibilities in regard to the qualification and validation of computer systems and data Integrity in clinical trials.

TGA has published a media release stating that they have started to undertake "remote and/or hybrid GMP domestic inspections" in place of on-site inspections.

Due to the effects of the corona pandemic, the European Commission is extending the comment period for the revision of Annex 1 of the GMP Guide.

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: Must there be regulations for remote access by service providers to GxP-critical systems and what data integrity requirements must they contain?