ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?
The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured? Find out about what standards for auditing starting materials APIC has defined in their new guideline here.
The GMP/GDP IWG at EMA is currently discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, and how to make risk based decisions to avoid drug shortages.
The British Medicines and Healthcare Products Regulatory Agency (MHRA) has published a report summarising GDP inspection deficiency data from its 2016 inspections.
Manufacturing and Importation Authorisation holders must not change the terms of the authorisation without prior approval of the authority. But also other GMP related changes require notification to the national competent authority.
Data integrity is for sure still a hot topic in inspections. But it seems inspectors are getting more back to the roots: document and batch record design and review.
Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.
Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.
The Federal Assembly has revised Art. 64a of the Therapeutic Products Act which regulates cross-border inspections. Read more about the changes in the Swiss Therapeutic Products Act.
