Good Laboratory Practice for Medicinal Plants: Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions, under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. Good Laboratory Practice (GLP) regulations became part of the regulatory bodies in the latter part of the 1970s in response to malpractice in research and development (R&D) activities by pharmaceutical companies and contract facilities used by them. In 1981, the Organization for Economic Cooperation and Development (OECD) also published GLP Principles and these now dominate the international arena. To date 30 countries (the member states of the OECD) have signed an agreement binding them to OECD GLP Principles. Other non-OECD member states have also adopted the OECD GLP Principles.
Objectives of GLP:
- GLP is to certify that every step of the analysis is valid or Not.
- Assure the quality and integrity of data submitted to the FDA in support of the safety of regulated products.
- GLPS has a heavy emphasis on data recording, record, and specimen retention.
General Requirements To Establish Good Laboratory Practice For Medicinal Plants
(a) Test Facility Organization and Personnel:
- Test Facility Organization and Personnel should know the GLP principles.
- Approve the study plan and appropriate SOP’s. Any modifications to the study plan should be documented and recorded by dated Signature.
- Availability of SOPs to the personnel.
- Raw data generated are to be fully documented and recorded.
- Study personnel is responsible for the quality of their data.
- Implementation of health precautions to minimize risk.
- Computerized systems used in the study should be validated.
- Ensure that after completion of the study, the study plan, the final report, raw data, and supporting material are archived.
(b) Quality Assurance Program:
- Quality assurance personnel should have access to the updated study plans and SOPs. The study plan contains information and verification.
- Conduct inspections to determine compliance of the study with GLP principles. There are three types of inspection-Study-based inspections, facility-based inspections, and process-based inspections.
- Records of such inspections should be retained and reported to the management
Test system facilities: Sufficient number of rooms assures the isolation of test systems and the isolation of individual projects involving substances or organisms known to be or suspected of being biohazardous. There should be storage rooms or areas as needed for supplies and equipment Areas should be available for the diagnosis treatment and control of diseases, to ensure that there is no unacceptable degree of deterioration of test systems.
Archive Facilities: Archive facilities should be provided for the secure storage and recovery of study plans, raw data, final reports, samples of test items, and specimens. Archive design and archive conditions should protect contents from early deterioration.
Waste disposal: Handling and disposal of wastes should be carried out in such a way as not to risk the integrity of studies. This includes; facility for the appropriate collection, storage, and disposal, decontamination, and transportation procedures.
(d) Apparatus, Material, and Reagents:
Apparatus used in the study of medicinal plants should be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures (SOPs). Apparatus and materials used in the study should not interfere with the test systems. Chemicals, reagents, and solutions should be labeled to indicate identity (with concentration), expiry date, and specific storage instructions. Information concerning the source, preparation date, and stability should be available. The expiry date may be extended based on documented evaluation or analysis.
(e) Test Systems and Reference Items:
Test systems include; physical, chemical, and biological test systems. Records of source date of arrival and arrival conditions of test systems should be maintained and documented. Proper identification of test systems in their container or when removed, cleaning and sanitization of containers and pest control agents to be documented. Receipt, handling, sampling, storage, stability of the test item in its vehicle, and samples for analytical purposes for each batch should be maintained and documented.
(f) Standard Operating Procedures (SOP):
A written procedure for a laboratory program is often written in chronological order of their action steps. They are written to explain how the procedures are supposed to work like; routine inspection, cleaning, maintenance, testing, calibration, actions to be taken in response to equipment failure, keeping records, reporting, storage, mixing, recovery of data, and analytical methods.
(g) Performance of the Study:
Performance of the study includes; preparing the study plan, the content of the study plan, and identification of the study. It also includes records, dates, references to test methods, information concerning the sponsor and facility, and the conduct of the study.
(h) Reporting of Study Results:
- It includes information on sponsors and test facilities.
- Starting and completion dates of the experiment.
- Quality assurance program statement.
- Description of materials and test methods.
- Storage (samples, reference items, raw data, final report, etc.).
(i) Storage, Retention of Records and Materials:
- It comprises the study plan, raw data, and samples.
- Inspection data and master schedules.
- Maintenance and calibration of the data.
- If any study material is disposed of before expiry the reason is to be justified and documented.
- Index of materials retained.
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