GMP NEWS 2017

Recently published, the EMA Guideline on the implementation of the requirements of the ICH Q3D Guideline provides support for API and medicinal product manufacturers. Learn more about what you have to consider with regard to the justification and documentation of elemental impurities in the dossier for a marketing authorisation.

In January 2017, FDA's Office of Pharmaceutical Quality revised the document "MAPP 5310.7" on the acceptability of standards from alternative compendia. This important FDA document is often unknown among the pharmaceutical industry. Learn more about the most important aspects of FDA's document "Acceptability of Standards from Alternative Compendia (BP/EP/JP)".

In March the CMDh published a new Q&A document to provide further guidance on the implementation of the EU Falsified Medicines Directive. Please find more information about the "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

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.

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.

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.

What can a Supply Chain Diagram look like? How to rely on vendor-supplied samples? These are just two examples of the questions in conjunction with the "Certification by a Qualified Person and Batch Release" being now answered by an inspectorate.

The British inspectorate MHRA has recently published a comprehensive document that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept must be applied. One essential element of that concept is EMA's Q&A Paper describing when a product should be classified as highly active. This Question & Answer Paper can be commented on until the end of April 2017. Read more here.

Beginning of February, the European Medicines Agency (EMA) published new information about Advanced Therapy Medicines and how to get to an increased ATMP development and patient access.