API starting materials – New Q&A document for ICH Q11

The selection of a starting material for the synthesis of an active substance and its justification is often one of the most crucial steps in the approval process. Assessors at regulatory agencies of the EU member states have to evaluate whether the data provided sufficiently justify the selection. The criteria for this are outlined in the 2012 ICH Q11 guideline – however, not in a sufficiently precise manner.

Process Validation never ends

It was 2011 when FDA published their Guidance for Industry: Process Validation: General Principles and Practices.
This document radically changed FDA interpretation of process validation.
According to the guidelines validation means “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” It will no longer be a formalized activity that is limited in time and, typically, to three validation batches.Read More →

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United Kingdom is now a “third country”: government position paper

In May 2017 the EU Commission and EMA made a clear statement: after 30 March 2019 the Unit Kingdom will become a ‘third country’.

In a common Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, the Commission and the Agency get the point strait that “all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET). That means that the U.K. will “become a ‘third country’”.Read More →

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About Me

A Biotechnologist with multidisciplinary expertise, enthusiastic and passionate about Pharmaceutical Quality Assurance. I have achieved considerable experience within multinational pharmaceutical corporations working as a primary quality contact with worldwide-based Contract Manufacturing Organizations and suppliers.

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