GMP NEWS 2018

The attempt to conceal hygiene deficiencies with inaccurate lab data resulted in a virtually inevitable Warning Letter after an FDA inspection. Read here, which violations of fundamental GMP rules for maintenance and cleaning of production equipment at an API facility were criticised by the inspectors.

In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.

The long-awaited draft of the new Annex 1 was published in December 2017. Besides mainly contents concerning sterile production, it also contains various updates on the manufacturing and distribution of water to be used in pharmaceutical production.

The United States Pharmacopeia, USP, posted the announcement of the elaboration of a new general chapter <922> on Water Activity.

If inspectors find deficiencies in quality control, they usually make sure to go into detail. Find out in which cases the invalidating of OOS results and exceeded bulk hold times are not tolerated in FDA inspections.

GDP inspections by supervisory authorities have grown in number and intensity. Many partners in the distribution chain also have customer audits to face. What does the ideal preparation for a GDP inspection look like?

Is a sampling plan based on the (√n+1) rule acceptable for determining the correct number of samples? Health Canada took up this question in their "Good Manufacturing Practices (GMP) Questions and Answers". Read more under which conditions the use of sampling key (√n+1) is possible.

The South Korean company Celltrion had received a so-called 483 FDA report as a result of inspections performed in May and June 2017. Deficiencies were mainly observed in the aseptic area. Due to the - in their opinion - insufficient answer to the 483 report, the FDA has now issued a Warning Letter.

Chinese manufacturer Zhejiang Ludao Technology received an FDA Warning Letter in February, 2018. During the FDA inspection, the missing Audit Trail Review for the HPLC system was particularly criticised.