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.

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GMPSOP

JUNE 16, 2023

Rather, it is a supplement to the validation study that demonstrates the analytical method’s reproducibility, or inter-laboratory precision. In the later part of the article, we will explain how to determine testing patterns and acceptance criteria for analytical method transfer exercises sometimes abbreviated as AMTE.

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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. Challenges include inadequate preparation, poor documentation, insufficient resource allocation, and lack of clear communication. What is Installation Qualification (IQ)?

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