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. Subscribe f.

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GMPSOP

MAY 31, 2024

If you are in the pharmaceutical business, regulatory authorities mandate that you develop, implement, and periodically review a validation master plan for qualifying your systems, processes, cleaning method, testing methodologies, equipment, facilities, etc. The process validation of formulated products (e.g.,

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GMPSOP

NOVEMBER 15, 2024

Stability testing overview for Pharmaceutical products Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Pharmaceutical products must maintain quality, safety, purity and efficacy throughout their specified shelf-life conditions up to their nominated expiration date.

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GMPSOP

OCTOBER 26, 2022

In general, you must formally validate all process steps, production equipment, cleaning methods, testing methods, computer systems and environment, facilities and utilities which are directly used for the manufacture of sterile and non-sterile products. This validation is relatively less comprehensive.

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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

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

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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