GMP News - Analytical Quality Control

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.

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.

The USP recently posted the announcement of its intent to cancel and redevelop the drafts of packaging chapters previously published in the Pharmacopeial Forum. Read more about USP´s chapters on glass containers and elastomeric closures.

Drug manufacturer Shanghai Weierya Daily Chemicals in China received an FDA Warning Letter in February 2018. During the inspection, the inadequate sampling when testing active pharmaceutical ingredients and excipients was criticised. Read more about the recent Shanghai Weierya FDA warning letter.

Recently a draft monograph on PAT has been published for comment in Pharmeuropa. Read more about Ph. Eur. chapter 5.25. Process Analytical Technology.

The Indian drug manufacturer Kim Chemicals received an FDA Warning Letter in October 2017. During an FDA inspection, it was criticised that not all medicinal products and the active substances they contained had been tested for compliance with the specifications. Find out more about the Kim Chemicals FDA Warning Letter.

End of December the USP published its revised chapter <381> Elastomeric Closures for Injections which became official on January 1, 2018.