Analytical Quality Control News

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.

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.

Drug manufacturer Shanwei Honghui Daily Appliance in China has received an FDA Warning Letter in December 2017. During the review, the FDA criticised the company's failure to check certificates of analysis for compliance with the specifications. Find more information in the recent FDA Warnig Letter to Shanwei.

The FDA's Office of Pharmaceutical Quality has published a new MAPP document (Manual of Policies and Procedures) on acceptance criteria and specifications for impurities. In provides principles on the determination of specifications and acceptance criteria for non-mutagenic impurities in authorisation applications, based on clinical relevance. Read more about the Office of Pharmaceutical Quality's new FDA document.