GMP News

Process controls have become customary in pharmaceutical processes. The aim is to monitor a process and improve it if possible. Statistical process control (SPC) is viewed as one option to implement Ongoing/Continued Process Verification. PharmEuropa has now published a new draft chapter on the topic.

A company in China has created GMP documents only for the purpose of inspection. With serious consequences.

It has hardly worked out anywhere: the falsification protection project has not been properly adapted EU-wide and discontentment is spreading amongst pharmacists.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.

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.

The brand new and completely revised and enlarged 2019 edition of the Defect Evaluation List for Rubber Parts has been published.

In order to encourage stakeholders to take the opportunity to send comments on the application of AQbD to pharmacopoeial standards, the MHRA provides some Questions and Answers.

The FDA has clear expectations about cGMP compliance in an analytical laboratory. Read more about what the cGMP-compliant running of chromatographic systems in a quality control laboratory should look like.

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.

The ISPE Baseline Guide Vol. 5 on Commissioning & Qualification has been in place since 2001 and was thus no longer up to date. Recent developments, e.g. towards a lifecycle model, were not reflected in the document. Now the ISPE Baseline Guide Vol. 5 has been completely revised. 

Under the heading "CDRH's Experiential Learning Program", the FDA offers an interesting advanced training program. It is aimed at FDA employees who are "reviewers", i.e. who evaluate medical devices as part of the "approval procedure". The idea behind the program is...

Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them.