GMPSOP

JUNE 15, 2025

Subscribe The microbiology quality control laboratory plays an important role in controlling microorganisms and sometimes enumerates and identifies microorganisms present in samples. – Test method validation and change control – Documentation – Sample handling and storage 2. – Production environments.

Pharmaceutical Manufacturing

GMPSOP

MAY 31, 2024

The validation master plan provides the first line of defense that all required validation and qualification activities are performed on a schedule and that their processes are compliant with GMP guidelines. You can read our article “ Equipment Cleaning in Pharmaceutical ” to explore cleaning validation further.

Documentation

GMPSOP

APRIL 3, 2023

Adapted and non-standard methods must be validated. Protocols are only used for specific projects such as method validation testing or equipment qualification. – Methods for data analysis and interpretation, including the statistical techniques to be used.

Documentation

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

GMPSOP

SEPTEMBER 27, 2023

However, you must validate the condition and efficacy of their use by conducting trials. Cleaning validation, including analytical method validation, should be conducted for the new product. If it is not, analytical method validation is required. Additional documents included each month.

Method Validation