GMPSOP

MAY 31, 2024

Following are some examples of validation studies which should be included in the validation master plan: 1. Process validation master plan The process validation master plan accounts for all manufacturing and packaging processes directly employed in the manufacturing and packaging registered products.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

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.

Packaging 59

Packaging Dosage Documentation Labelling 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

JUNE 16, 2023

According to USP <1224> , method transfer is defined as the documented process that qualifies a laboratory (RL) to use an analytical method originating from another laboratory (TL), regardless of whether it’s internal or external. Suggested transfer acceptance criteria for the assay method.

Documentation 52

Documentation Dosage Communication Method Validation 52

GMPSOP

MARCH 4, 2023

If my cleaning methods are not validated would they cause contamination of my products? What is the probability my cleaning methods weren’t validated? Should I implement a more robust cleaning method validation to mitigate such risk? Packaging and labelling operations v. Manufacturing processes iv.

Documentation 52

Documentation Communication Method Validation Packaging 52

Express Pharma

DECEMBER 23, 2024

Dr Dikshit discussed the importance of validation in the quality control process, emphasising the need for user requirement specifications for standard equipment. He presented on good practices in quality control, highlighting the importance of appropriate qualifications and experience, and adequate facilities for storage and sampling.

Documentation 104

Documentation Method Validation Pharmaceutical Manufacturing Packaging 104