Remove Data Entry Remove Events Remove Method Validation
article thumbnail

What are the elements of quality control process in pharmaceuticals

GMPSOP

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Validated test method A test method comprehensively describes all procedures used in sample analysis. Typical documentation in a quality control process?

article thumbnail

Overview of GLP requirements on everyday laboratory operations

GMPSOP

– Record or capture all generated raw data directly, promptly and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. – Test method validation protocols, data and reports – Other records and data i.

article thumbnail

Typical GMP documentation in a quality control laboratory

GMPSOP

Data management policy : This policy governs activities for data entry, storage, and retrieval to ensure the integrity of laboratory results. Record keeping policy : this policy outlines procedures for documenting laboratory activities, including data, results, and observations.