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Cleaning validation protocol for pharmaceutical industry

GMPSOP

Cleaning validation verifies that the cleaning procedure can consistently and significantly reduce the amount of active ingredients, excipients, and cleaning agents to a concentration within the acceptance limit. Why is cleaning validation required? If it is not, analytical method validation is required.

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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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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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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.

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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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What are the elements of quality control process in pharmaceuticals

GMPSOP

Validated test method A test method comprehensively describes all procedures used in sample analysis. Analytical test method validation guarantees that your test method is robust enough to provide evidence if your product meets the predetermined product specification or conforms to the failure of a product.