Communication Information Method Validation 
GMPSOP
OCTOBER 26, 2022
By implementing robust validation protocols, pharmaceutical companies can ensure that their products are safe, effective, pure and of the highest quality. A scenario where validation is required The management of your company has recently decided to install an information management system in analytical laboratory.
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
You must record all important information, including test data, observations, conclusions, etc. The information may be available in a manual but it may need to be tailored to the protocol. Provide installation qualification methodology to be used State how the validation study will meet site and cGMP requirements.
FDA Law Blog: Biosimilars
FEBRUARY 13, 2025
The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.
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