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
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