GMPSOP

NOVEMBER 19, 2023

The scope of this article applies to all regulated medicinal products manufactured at a GMP site that undergo annual product quality review. The content of this article does not supersede or replace any local or international regulatory requirements. The effectiveness of the validation must be determined.

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GMPSOP

DECEMBER 24, 2023

This article will focus on G(C)LP due to its significance in everyday laboratory operations. Laboratory documentation and records that should be available include: – Test methods and test reports – Laboratory notebooks/sheets, instrument records, and calculations – Conditions of tests and instrument settings.

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GMPSOP

JULY 23, 2023

If you are completely unfamiliar with what is installation qualification then we suggest you read the article Validation in Pharmaceutical Industry first. Validation of testing methods: Validate all testing methods used during the qualification process to ensure the accuracy and reliability of results.

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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.

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GMPSOP

JUNE 16, 2023

Importance of acceptance criteria in analytical method transfer Pharmaceuticals quality assurance & validation procedures GMPSOP Importance of acceptance criteria in analytical method transfer Last modified: June 17, 2023 Table of Contents What is analytical method transfer?

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