The United States Pharmacopeia, USP, posted the announcement of the elaboration of a new general chapter <922> on Water Activity.
The European Commission published its final Bisphenol A (BPA) Regulation. The Regulation lowers the BPA limit from currently 0.6 mg/kg to 0.05 mg/kg. This limit also applies for varnishes and coatings. Read more about the final Commission Regulation (EU) 2018/213.
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.
During the last year, the notifications on mechanical defects and reported suspicions of counterfeits increased. Distributors should also be interested in these figures.
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?
The European GDP Association evaluated the current implementation status of the EU-GDP guidelines in a survey. The response was interesting.
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.
The coming into force of the new FDA guidance on process validation in 2011 led to a shift in paradigm. Validation is a three-stage life cycle now and also includes commercial production in stage three. What does that mean for implementing the FDA proces validation guidance though?
On 27 November, 2017, the EMA's Committee on Herbal Medicinal Products (HMPC) published the HMPC meeting report about their 79. meeting held from 20-21 November, 2017. Learn more about the key issues discussed during the EMA HMPC meeting.