GMP News - Pharmaceutical Technology

A US-American pharmaceutical manufacturer received a Warning Letter from the FDA in November 2019 due to microbial issues in the water system, deficiencies in qualification/validation and insufficient stability data. Read more here.

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.

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?

Once again, an Indian pharmaceutical manufacturer has received a Warning Letter from the US-American FDA due to deficiencies discovered during an inspection. The Letter focuses on deficiencies in the validation and the handling of OOS results in the laboratory. Read more here

In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.

With the revision of Annex 15 in October 2015, the topic of requalification has become more important. Time intervals for the assessment of the equipment with regard to the qualification status and for the requalification itself should be justified. Criteria for the assessment should be defined. This is sometimes difficult. Chapter 9 of the revised ISPE Baseline No 5 Commissioning & Qualification of June 2019 on the periodic review can be helpful here.

In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.