Wikipedia

Search results

Thursday, December 14, 2023

Do you know how to Evaluate your Good Laboratory Practices|GLP| Good Laboratory Practices

To Evaluate and Documented your Good Laboratory Practices (GLP) to ensure the consistency, reliability and integrity of pharmaceuticals, chemicals, and biotechnology product analysis laboratory, here are some parameters that are must be included in your evaluation protocol (but not limited to:-

1.0         Documentation Practices for Issuance and Controls

2.0         Analyst Qualification and Personnel Training

3.0         Impurity and Assay Standards Management

4.0         Volumetric Solution Handling and Management

5.0         Stability Program effectiveness

6.0         Standard Operating Procedures (SOPs) all laboratory procedures

7.0         Instrument Calibration and Maintenance

8.0         Quality Control (QC) /Quality Assurance (QA) audit teams

9.0         Facility and Equipment suitability for the intended purpose

10.0      Raw, in-process, Finished, Stability study Sample Management for the proper handling, storage, and disposal.

11.0      Data Integrity and secure storage and backup provisions

12.0      Personnel Health and Safety of laboratory personnel

13.0      Quality Management System (OOS/OOT/Lab Incident/OOC)

14.0      Records Archiving:

Thanks, For More stuff Stay Tuned

No comments:

Post a Comment