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FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

The panel also discussed the role of analytical method validation when outsourcing testing and the necessity of Excel sheet validation. The panellists patiently addressed participants’ questions on quality control practices in pharmaceutical manufacturing, particularly in the microbiological and chemical analysis sections.

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A rapid microbiological method case study for advanced therapy medicinal products

European Pharmaceutical Review

Rapid microbial methods (RMMs) are no longer a luxury but a necessity” Now, it appears that pharmaceutical manufacturing has turned a corner. As part of the implementation, users no longer require alternative method validation, as these test methods have become known to be as reliable as their traditional counterparts.

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Effective Control of Microorganisms in Pharmaceutical Manufacturing

GMPSOP

Effective Control of Microorganisms in Pharmaceutical Manufacturing Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST The control of microorganisms in pharmaceutical production ensures that they stay at acceptable levels. – Storage of media must be controlled.

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Understanding endotoxin cartridge testing: frequently asked questions

European Pharmaceutical Review

With over 22 years of experience, she has worked as a QC microbiologist in cell therapy and non-sterile pharmaceutical manufacturing, specialising in environmental monitoring and method validation. Sherri Hopple is a subject matter expert in bacterial endotoxin testing.

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Concept of validation in pharmaceutical industry

GMPSOP

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.

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Overview of pharmaceutical quality control steps and implementations

GMPSOP

Test method validation in quality control Analytical Method Validation for Quality Control Test method validation generally means the same as analytical method validation, where the terms are interchangeable. Maintenance programs must be documented for laboratory equipment.

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Validation master plan (VMP) – when and how to create one?

GMPSOP

You can read our article “ Equipment Cleaning in Pharmaceutical ” to explore cleaning validation further. If you need help with complete guidance, please refer to the cleaning validation master plan. Method validation master plan? Create a master plan listing all products, specifications, and test methods.