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By Admin
#2281
We often confused by the differences between Good Laboratory Practice (GLP) regulation and Good Manufacturing Practice (GMP) regulations as they relate to laboratory testing. This is understandable, since both GLPs and GMPs cover lab testing but are very different. In addition, scientists and quality control/quality assurance personnel participating in GLP and GMP studies play different roles.

GLP and GMP regulations pertaining to testing serve two different purposes. The GLPs are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. In contrast, the GMPs are intended to demonstrate to the FDA whether or not individual batches of a regulated product are manufactured according to pre-defined manufacturing criteria.

In general, "lot release" or "lot conformance" testing of regulated products produced for sale, like finished pharmaceuticals, should be done under GMP. Safety testing and efficacy testing should be done under the GLP testing regulations. It is a matter of debate whether validation studies should be done under GLP or GMP. It may depend on what is being validated; in some cases either GLP or GMP may be appropriate.

GLP vs. GMP

1. Study Director

GLP:

Single point of contact for the study, with overall responsibility and control of the study and its components. Appointed by Testing Facility Management.

GMP:

No Study Director assigned or appointed. No single point of contact is required.

2. QA Vs. QC

GLP:

Single point of contact for the study, with overall responsibility and control of the study and its components. Appointed by Testing Facility Management.

GMP:

Quality Control Unit has responsibility and authority to approve or reject all procedures and aspects of testing/manufacturing. Is overall quality system.

3. Testing Facility Management

GLP:

Is responsible for designating a Study Director with appropriate education / training for each study. Ensures there is a Quality Assurance Unit separate from the personnel engaged in the study. Ensures facility, personnel, equipment, etc. is available and complies with the GLPs.

GMP:

Supervisors should have proper training. Responsibilities should be in written procedures and followed. Is oversight function.

4. Type of Testing Conducted

GLP:

Open-ended determination of product performance, often for submission to the EPA or FDA for pre-market approval.

GMP:

Determination of whether or not the product/sample has met manufacturing specifications.

5. Facility

GLP:

Design and construction must be suitable to the type of testing conducted, with separation of areas for minimizing mix-ups/contamination. Lighting, plumbing, sewage, washing facility regulations are not mentioned under GLPs.

GMP:

Design construction must be suitable to the type of testing conducted, with separation of areas for minimizing mix-ups/contamination. Lighting, plumbing, sewage, and washing facility requirements are specified under GMPs.

6. Equipment

GLP:

Equipment must be appropriate, maintained, and the state of equipment documented to provide study re-constructability. Data-generating equipment is calibrated.

GMP:

Equipment must be qualified for use in manufacturing processes. Data generating equipment for product testing purposes is calibrated. The accuracy, sensitivity, specificity, and re-producibility of test methods shall be established and documented.

7. Standard Operating Procedure (SOP) / Written Procedure

GLP:

Drafted by any qualified personnel, approved by Testing Facility Management.

GMP:

Drafted by any qualified personnel, approved by Quality Control Unit.

8. Standard Operating Procedure (SOP) / Written Procedure

GLP:

Each study requires a specific study protocol indicating study objectives and methods for conduct and is approved by both the Study Sponsor and Study Director prior to initiation. Protocol overrides SOPs.

GMP:

Study-specific protocols are not required. Standard written procedures are followed.

9. Master Schedule

GLP:

An index of all studies is maintained by the Quality Assurance Unit.

GMP:

Master Schedule is not addressed.

10. Records and Reports

GLP:

Signature or initials of personnel conducting all procedures, preparations, calibrations, etc. are required along with dates completed and must be on all records. Records are maintained in secure archives for at least 5 years following date of registration if used to support a marketing permit or 2 years following study completion/termination. Archivist is responsible for archives and ensures security of documentation.

GMP:

Signature of both the personnel conducting procedures and personnel verifying steps of procedures must be on all records (dual control of procedures/records). Records are maintained (not specified in archives) for at least 1 year following product expiration date.

11. CAPA System

GLP:

Not required.

GMP:

Required.

More About GMP:

Reference :
https://www.linkedin.com/pulse/glp-vs-g ... a-behera-1
#2490
Both GLP and GMP are regulations governed by the Food and Drug Administration that are imposed for ensuring the safety and integrity of drugs. GMP stands for Good Manufacturing Practises whereas GLP stands for Good Laboratory Practises. GLP is used for non-clinical laboratory studies, and the GMP is applied for the supplies or products used by human beings. In the GLP the type of testing conducted to determine the product performance while providing the EPA or FDA with a clear & auditable record of open-ended studies, where the GMP is done to determine whether the product/sample has met the specified specifications or not.

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