For beginners to regulated pharmaceutical industry, GLP(Good Laboratory Practice) and cGMP(Current Good Manufacturing Practice) probably are the two most encountered regulatory standards. In some case, it may feel like very similar in terms of analytical testing. Here is the summarized table of difference between GLP and GMP for testing.
| Topic | GLP | GMP |
| Study Director | Single point of contact for the study, with overall responsibility and control of the study and its components. Appointed by Testing Facility Management. | No Study Director. May have single point of contact, but required. |
| Quality Assurance Unit vs. Quality Control Unit | Quality Assurance Unit inspects each study and periodically inspects the facility to ensure the integrity of the studies and compliance with the GLPs. QA must separate from the personnel engaged in the study. Only have oversight function, have no quality control. | Quality Control Unit has responsibility and authority to approve or reject all testing/manufacturing procedures . Is the overall quality system. |
| Testing Facility Management | 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. | Supervisors should have proper training. Responsibilities should be in written procedures and followed. Is oversight function. |
| Type of Testing Conducted | Open-ended determination of product performance, collect data for submission to the EPA or FDA for pre-market approval. | Determination of whether or not the product/sample meet pre-defined manufacturing specifications. |
| Facility | 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 but are usually considered. | 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 need specified under GMPs. |
| Equipment | Equipment must be appropriate, maintained, and the state of equipment documented to provide study reconstructability. Data-generating equipment is calibrated. | Equipment must be qualified for use in manufacturing processes. Data generating equipment for product testing purposes is calibrated. The accuracy, sensitivity, specificity, and reproducibility of test methods shall be established and documented. |
| Standard Operating Procedure (SOP) / Written Procedure | Drafted by any qualified personnel, approved by Testing Facility Management. 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. | Drafted by any qualified personnel, approved by Quality Control Unit. Study-specific protocols are not required. Standard written procedures are followed. |
| Master Schedule | An index of all studies is maintained by the Quality Assurance Unit. | Master Schedule is not addressed. |
| Records and Reports | 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. | 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. |
| CAPA(Corrective and Preventive Action) System | Not required. | Required. |