How did the EMA Q&A Document on the use of PDE Values come about?
In June you could already read about the Q&As of the European Medicines Agency (EMA) on the use of PDE (HBEL) values in connection with cross contaminations and cleaning validation. The EMA has now published a report which describes how these questions and answers came into being.
During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. Learn more about the Non-Compliance Report issued on behalf of the EMA.
FAT & SAT not frequently used as Part of Qualification - ECA Modern Qualification Survey Results
The ECA set up a survey to find out to what extent qualification and validation programmes are integrated as actually made possible by the EU Annex 15 and the FDA Process Validation guide – and to what extent suppliers are involved. Read more about the Qualification/Validation Survey results.
GCP: FDA Draft on Data Integrity in Clinical Studies
The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of Electronic Data Files and Statistical Analysis Programs.
Manufacturing without process validation and stability testing - the quickest way to receiving a warning letter
If a company neglects basic GMP principles, it is not very likely for it to pass an FDA inspection. Read here, what violations concerning the testing of incoming materials, the final testing of finished products and the control of production processes lead to a warning letter.
Warning letter due to non-validated Analytical Methods
Procedures for the analysis of GMP-liable products must be validated. Read here, what deficiencies involving the validation of analytical methods and the handling of OOS results almost inevitably lead to a Warning Letter.
FDA Requirements on Process Validation - a Warning Letter provides Information
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?
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.