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The expectations from the EU GMPs in respect of investigations is referenced in the Chapter 1. of the GMPs Pharmaceutical Quality System.
The role of corrective actions and/or preventative actions (CAPAs) in identifying and resolving the deficiency investigation.
The types of techniques to be employed during the investigation process with advantages and disadvantages for the different types of failure investigations.
Understand that the use of risk assessments to reach appropriate decisions should be based on evidence, not opinions.
Findings should not be biased to enable batch release decisions but to come to the correct GMP decision whether this is batch rejection or not.
Rob Walker GMP Consultancy Limited, Director
Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry. He has over 30-year experience in the Pharmaceutical industry including 25 years as a Qualified Person. After 16 years in senior management at CP Pharmaceuticals, the last 7 as Quality Director, he is now a director of his own GMP consultancy company operating across the Global Market. Rob has extensive GMP Manufacturing and Quality experience covering a wide range of dosage forms, in particular aseptic sterile products, and has successfully managed GMP inspections by MHRA and FDA for primary and secondary manufacturing in the UK and overseas. He has performed GMP audits and training encompassing all elements of the global pharmaceutical supply chain. A member of a number of pharmaceutical industry professional organizations, Rob has delivered numerous presentations to Industry/Regulatory forums in both the EU and the USA on current GMP issues. He has edited technical reports for professional bodies on steam sterilization, and contributed to pharmaceutical industry monographs on media fills and integrity testing of sterile products. He has also represented the UK Pharmaceutical Industry in regulatory meetings in the EU and USA.
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