European Pharmaceutical Review

NOVEMBER 21, 2024

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.

Method Validation 52

Method Validation Pharmaceutical Manufacturing 52

GMPSOP

JUNE 9, 2024

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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Method Validation Documentation Health and Personal Care Stores Labelling 52

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.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

GMPSOP

MAY 31, 2024

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.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

OCTOBER 28, 2023

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.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

SEPTEMBER 27, 2023

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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Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

Express Pharma

DECEMBER 23, 2024

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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