Standard Operating Procedure for Good Laboratory Practices (GLP) Compliance

1) Purpose

This SOP outlines the procedures for ensuring compliance with Good Laboratory Practices (GLP) to ensure the integrity, reliability, and quality of laboratory data generated for pharmaceutical product testing and research.

2) Scope

This SOP applies to all laboratory personnel involved in conducting analytical testing, method validation, stability studies, and other laboratory activities related to pharmaceutical products within the facility.

3) Responsibilities

The Laboratory Manager or designated personnel are responsible for overseeing GLP compliance. Analytical chemists, laboratory technicians, and quality assurance personnel are responsible for implementing GLP requirements in their respective areas.

4) Procedure

4.1 Facility and Equipment

1. Maintain laboratory facilities and equipment in a clean, orderly, and suitable condition for their intended use.
2. Ensure calibration, qualification, and maintenance of laboratory instruments and equipment.

4.2 Personnel Training

1. Provide training to laboratory personnel on GLP principles, procedures, and specific analytical methods.
2. Ensure personnel are competent and qualified to perform assigned tasks and adhere to GLP requirements.

4.3 Standard Operating Procedures (SOPs)

1. Develop, implement, and maintain SOPs for all laboratory activities and testing procedures.
2. Ensure SOPs are followed consistently and are periodically reviewed and updated as necessary.

4.4 Document Control

1. Maintain accurate and complete documentation of all laboratory activities, including test methods, protocols, raw data, calculations, and reports.
2. Ensure proper version control, approval, and retention of all laboratory records and documents.

4.5 Analytical Testing and Method Validation

1. Conduct analytical testing and method validation according to approved procedures and regulatory requirements.
2. Verify analytical methods for accuracy, precision, specificity, and robustness.

4.6 Quality Control

1. Implement quality control measures to ensure the accuracy and reliability of laboratory data.
2. Participate in proficiency testing programs and conduct internal quality audits to verify compliance with GLP.

4.7 Sample Management

1. Establish procedures for sample receipt, handling, storage, and disposal to prevent contamination, mix-up, or degradation.
2. Ensure traceability and integrity of samples throughout the testing process.

4.8 Reporting and Documentation

1. Prepare accurate and timely reports of laboratory testing results, ensuring data integrity and compliance with regulatory requirements.
2. Review and approve laboratory reports prior to release, documenting any deviations or discrepancies.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GLP: Good Laboratory Practices

6) Documents, if any

GLP Compliance Checklist, Training Records, SOPs, Analytical Method Validation Reports, Laboratory Testing Records, Quality Control Records, Sample Handling and Disposal Procedures

7) Reference, if any

Regulatory guidelines such as FDA Good Laboratory Practice Regulations (GLP) for Nonclinical Laboratory Studies (21 CFR Part 58), OECD Principles of Good Laboratory Practice, ICH Harmonised Tripartite Guideline for Good Clinical Practice

8) SOP Version

Version 1.0