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It is also possible to apply for a Certificate of Suitability for API mixtures. However, a few particularities have to be considered. Here, you can read about what must be observed when applying for a CEP for an API/auxiliary substances mixture or an API/antioxidant mixture.
It its cGMP regulations for medical devices (21 CFR 820 (Quality System Regulations), the FDA also addresses the topic of validation (21 CFR 820.75). In the course of its inspections, the authority reviews the validation of the manufacturing processes. The FDA criticised according deficiencies at a Taiwanese medical devices manufacturer with a Warning Letter.
Last year the MHRA published a 11-page guidance about the re-manufacturing of single-use medical devices (SUDs). Alhough only valid for the UK the content of the MHRA Guidance on Single-Use Medical Devices is interesting.
Since February, 16th 2017 you can comment on a concept paper of the EMA on the development of a guideline with regard to the quality requirements of "combination products" - called "Drug-Device-Combination" (DCC) in the document.
The USP is requesting early input from stakeholders on two new proposed General Chapters regarding the characterization of viscoelastic properties of semisolids. Read more about the proposed chapters <915> Measurement of Structural Strength of Semisolds by Penetromety and <1912> Measurement of Hardness of Semisolids.
The European Medicines Agency (EMA) recently published Questions and Answers on good clinical practice (GCP) on its website. These Q&As include questions and corresponding answers regarding general considerations on how contracting should be addressed and contractual arrangements with vendors for electronic systems. Find out more about EMA´s "GCP matters" Q&As.