Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements?
The ICH M9 Guideline and the corresponding Q&As reached Step 4 of the ICH Process in November 2019.
The FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations".
Will the revised Annex 1 introduce new GMP requirements for lyophilized products?
Will the revised Annex 1 provide guidance for the application of GMP to sterile primary packaging materials?
In an interesting Warning Letter, the FDA replies to a letter from a pharmaceutical manufacturer that had received a 483 deficiency report in which the FDA criticized, among other things, deficiencies in process validation. Read more about the correspondence.
On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.
The Finnish Medicines Agency (Fimea) recently stated that Cannabidiol (CBD) is controlled as a medicine in Finland.
Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections, as a recent FDA Warning Letter shows.
The nickel plating of surfaces is a good and high-quality method to protect components or surfaces from corrosion. At the same time, the question is repeatedly asked whether components treated in this way may be used in the GMP area. Read more here.