Understanding The Difference Between Good Manufacturing Practice Vs Good Laboratory Practice

By Author: John
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GLP stands for good laboratory practices, whereas GMP stands for good manufacturing practices. The Food and Drug Administration is in charge of both the GMP and the GLP rules (FDA). These rules are put in place to protect the purity and safety of medicines. The GLP is seen as less expensive and burdensome when compared to the GMP. Good Manufacturing Practices are used for items that are created for human use, whereas Good Laboratory Practices are used for non-clinical laboratory investigations.

The FDA had come forward with a proposal in 1976 for regulating Good Laboratory Practices after certain irregularities were found in non-clinical studies. GLP testing facilities are intended to preserve the integrity of scientific findings. They give an auditable and unambiguous record of open-ended research projects to the FDA and EPA. Efficacy and safety testing should be carried out by GLP lab testing requirements. Whereas GMP quality control is intended to verify to the FDA whether or not regulated items are created by defined manufacturing criteria. GMP lab testing should be used for finished medicines and other regulated ...
... items manufactured for sale.

The areas that come under Good Laboratory Practices are personnel and organization, testing facilities, equipment, testing and controls, records, reports, and protocol for and conduct of non-clinical labs. The areas that come under GMP are facilities and buildings, equipment, production, process control, packaging and labeling, laboratory controls, and returned/salvaged drug products. Here are some of the major differences between GMP and GLP. Let's have a look at it.

1. While Good Laboratory Practice is applied to non-clinical laboratory studies, Good Manufacturing Practices are applied to products that are developed for use by human beings.

2. The GLP regulations were coded in 1978 as 21 Code Federal Regulations Part 58. The Good Manufacturing Practice was established in 1963 21 CFR Part 211 as the current Good Manufacturing Practice for pharmaceutical products.

3. GMP certificates are given to those who comply with biological, biopharmaceutical, pharmaceutical development, and manufacturing industries. These entities will get the Good Manufacturing Practices certification. Where GLP certificates are given to those who comply with the Pharmaceutical industry and Medical Devices industries.
4. In the GLP the CAPA system is not required whereas in the GMP CAPA system is required.

5. The GLP regulations were coded in 1978, and the Good Manufacturing Practices were established in 1963.

6. In GLP the Study Director is a single point of contact for the study, with overall responsibility and control of the study and its components. Appointed by Testing Facility Management. Where in the GMP No Study Director is assigned or appointed. No single point of contact is required.

7. The quality assurance unit inspects critical phases of each study and periodically inspects the facility to inform Testing Facility Management of the integrity of the studies and compliance or non-compliance with the GLPs. Is entirely separate from the personnel engaged in the study. Is an oversight function only, not a quality system or control. Also, the GMP Quality Control Unit has the responsibility and authority to approve or reject all procedures and aspects of testing/manufacturing. Is an overall quality system.

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

9. In the GLP SOP documents are drafted by any qualified personnel and approved by Testing Facility Management. And GMP SOP documents are drafted by qualified personnel and approved by Quality Control Unit.

10. The GLP master schedule is an index of all studies maintained by the Quality Assurance Unit.