Remove Dosage Remove Method Validation Remove Pharmaceutical Manufacturing
article thumbnail

Overview of pharmaceutical quality control steps and implementations

GMPSOP

Test method validation in quality control Analytical Method Validation for Quality Control Test method validation generally means the same as analytical method validation, where the terms are interchangeable. Maintenance programs must be documented for laboratory equipment.

article thumbnail

Cleaning validation protocol for pharmaceutical industry

GMPSOP

Cleaning validation verifies that the cleaning procedure can consistently and significantly reduce the amount of active ingredients, excipients, and cleaning agents to a concentration within the acceptance limit. Why is cleaning validation required? If it is not, analytical method validation is required.

article thumbnail

What are the elements of quality control process in pharmaceuticals

GMPSOP

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.