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Manufacture Standards & Regulation, Quality & Compliance

Quality, Not Quantity

What is the best way to define your GMP implantation strategy? Many will be familiar with a traditional gap analysis starting with a GMP Guideline. You take the list of requirements and compare them line-by-line with your activities to see whether you comply and then implement action to close any gaps. This approach is moderately effective but limited in terms of flexibility and how much you can actually learn about your activities.

My preference is to use a risk-based approach, where you systematically examine your activities, process by process to identify, analyze, evaluate, treat, monitor and communicate the risks in their proper context. However, many risk-based approaches are compromised by failing to understand the understand the difference between risks and hazards.

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About the Author

author Iain Moore

Iain Moore

At university, Iain Moore spent time deciphering nuclear magnetic resonance spectra to determine the atomic structure of organometallic products that he had synthesized. It was an inspiring and captivating area, but didn’t satisfy his need to apply the knowledge to real world problems. “A career in industry – predominantly with the oleochemical supplier Croda – put all my problem solving skills to the test.” Combining these skills with the desire to help people do better led him naturally to quality assurance, and then to working internationally on the definition of best practice standards for pharmaceutical excipients and now bio-based products. “Along the way, I like to think I’ve helped solve one or two real world problems.”

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