Quality, Not Quantity
Qualitative risk assessments are a great way to approach quality management and train your operators at the same time.
Iain Moore | | Opinion
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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