GMPSOP
OCTOBER 26, 2022
What is method validation in pharmaceutical industry? Analytical method validation involves demonstrating that the analytical methods used to test the quality of your product are accurate, reliable and reproducible which is critical for ensuring the quality and safety of your products.
GMPSOP
JUNE 16, 2023
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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GMPSOP
MARCH 4, 2023
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?
GMPSOP
JULY 23, 2023
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.
FDA Law Blog: Biosimilars
FEBRUARY 13, 2025
The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Additionally, a failure is NOT considered unresolvable if a root cause analysis of the failure reveals it is not related to specific aspects of the PCCP. In such cases, performance testing may be conducted again.
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