GMPSOP

JUNE 9, 2024

From starting materials to testing pharmaceutical products coming out of the manufacturing process, quality control is the only function that detects unknown defects early and allows for timely correction. This means that the analytical methods consistently generate true results with precision and accuracy every time.

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

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. Method validation master plan?

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

GMPSOP

OCTOBER 26, 2022

Additionally, validation includes continuous monitoring and re-evaluation to ensure that the product or process remains in compliance with the established requirements. By implementing robust validation protocols, pharmaceutical companies can ensure that their products are safe, effective, pure and of the highest quality.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

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.

Documentation 52

Documentation Packaging Method Validation Process Improvement 52

GMPSOP

DECEMBER 24, 2023

The term Good (Control) Laboratory Practice G(C)LP describes the regulations and practices concerning pharmaceutical laboratory testing as part of Good Manufacturing Practice (GMP). This article will focus on G(C)LP due to its significance in everyday laboratory operations. 27: Key Personnel – Sections 6.5-6.6:

Documentation 52

Documentation Method Validation Packaging Data Entry 52

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

NOVEMBER 15, 2024

This article will explore different types of stability studies, designing of stability trial testing program, aspects of stability protocol, different storage conditions, determination of shelf life by analysing stability trial results and common problems that can invalidate a stability testing. </p>

Packaging 59

Packaging Dosage Documentation Labelling 59