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Importance of acceptance criteria in analytical method transfer

GMPSOP

What is the analytical method transfer protocol? Properly transferring a method between two laboratories requires meticulous planning and a thorough assessment of various factors. Which method transfer strategies to choose from? QA maintains communication between the laboratories.

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What is quality risk management in pharmaceutical?

GMPSOP

According to FDA Guidance for Industry – Q9 Quality Risk Management , “Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. If my cleaning methods are not validated would they cause contamination of my products?