GMP NEWS 2019

Water systems are one of the most important systems in the pharmaceutical industry. What are the GMP requirements for the qualification and running of these systems? The US GMP regulations (21 Code of Federal Regulation (CFR) 210/211) do not provide much concrete information on this. There is still a Guide to Inspection for FDA inspectors from the early 90s. So, what does the FDA expect today? A current Warning Letter provides a few answers.

In September, a US pharmaceutical manufacturer received a Warning Letter from the FDA due to GMP violations in the areas of equipment cleaning, drug stability and handling complaints.

The new ICH Q12 Guideline for Post-Appproval Changes has been adopted in Singapore in November 2019. The document provides guidance on a framework to facilitate the management of post-approval CMC changes.

Supplement 11.3 of the Swiss Pharmacopoeia (Ph. Helv.) includes a new monograph on Cannabis Flowers. 

Production and laboratory processes are for sure still a hot topic in inspections. But investigators are also focusing on the role of the Quality Unit and Quality Oversight.

FDA's Warning Letters provide a valuable source of detailed information and can be helpful in preparing for an inspection, making a more detailed analysis worthwhile. Read more here about what FDA inspectors have discovered in recent months regarding frequent weaknesses at GMP-liable pharmaceutical manufacturers.

Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients.

The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?

ISO 22519 is a new available international standard dealing with the pretreatment and the production of purified water (PW) and water for injection (WFI).