Remove Communication Remove Labelling Remove Method Validation
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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?

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A step-by-step guide to successful installation qualification (IQ)

GMPSOP

Challenges include inadequate preparation, poor documentation, insufficient resource allocation, and lack of clear communication. Validation of testing methods: Validate all testing methods used during the qualification process to ensure the accuracy and reliability of results.