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.
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.
Microbiological testing of topical drug products to prove compliance with the specifications prior to release and correct labelling is mandatory for products applied to the skin. Find out, what GMP violations regarding the manufacturing, testing and labelling FDA inspectors found during an inspection.
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.
The guideline VDI 6022 Part 1 underwent substantial revisions and now contains many new obligations for manufacturers, planners, constructors, operators and supervisors of HVAC systems and air conditioners.
The ECA Pharmaceutical Microbiology Working Group completed the first chapter of their guidance on handling of microbiological deviations to support members in dealing with OOS and OOL results.