We are asked about the different inspection reports of the US-American health authority FDA (US Food and Drug Administration) again and again. In this newsletter, we would like to present the three most important documents to you. Read more.
Alongside validation, the (GMP-compliant) operation of computerised systems is also becoming an increasingly higher priority. A new GAMP Good Practice Guide gives comprehensive support on this matter. Read more here.
Which requirements do plastic packaging materials intended for packaging solid oral dosage forms and for packaging active pharmaceutical ingredients have to fulfil? The EMA's Q&A section provides important information.
European Pharmacopoiea: The Modern Microbiological Methods Working Party published a questionnaire to the revision of Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality Rapid Microbiological Methods. More details can be found here.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human has updated the Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Find further information here.
In a recent questions-and-answers paper, the question if, according to cGMP, the manufacture of 3 validation batches is required before a new active pharmaceutical ingredient or medicinal product can be marketed is answered by the FDA in the negative. The reasons for the no can be found here.
The final FDA Guidance for Industry on mechanical calibration of dissolution apparatus 1 and 2 was published in January 2010. Compared to the 2007 draft version, the guideline was completely revised; however, the conclusions and the recommended method for mechanical calibration remained unchanged. Read more here.
In the document "Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs", the FDA publishes statements on topical subjects. Recently, the authority published a statement on the number of annual media fills in relation to the number of shifts and depending on the use of isolators. Find more here.