If you work in the pharmaceutical, biotechnology, or medical device industry, you may have heard of GMP and GLP inspections. But what do these acronyms stand for, and how do they differ? In this article, you will learn the basics of GMP and GLP inspections, their purpose, scope, and frequency, and how to prepare for them.
GMP stands for Good Manufacturing Practice, and it refers to a set of standards and guidelines that ensure the quality, safety, and efficacy of medicinal products. GMP covers all aspects of the manufacturing process, from the design and validation of facilities and equipment, to the selection and testing of raw materials, to the documentation and control of procedures and records. GMP inspections are conducted by regulatory authorities, such as the FDA in the US or the EMA in the EU, to verify that manufacturers comply with GMP requirements and follow the approved specifications and protocols.
While GLPs are used in the context of research and development, GMPs apply when products being manufactured for sale. Both can apply to product testing, but during different phases of the product development process.
GLP stands for Good Laboratory Practice, and it refers to a set of principles and practices that ensure the reliability, integrity, and reproducibility of non-clinical studies. GLP covers the planning, conduct, reporting, and archiving of studies that involve animals, plants, microorganisms, or chemicals, and that are intended to support the safety assessment of medicinal products. GLP inspections are conducted by national or international authorities, such as the OECD or the EPA, to verify that laboratories follow GLP standards and generate valid and accurate data.
GMP and GLP inspections have different objectives, scopes, and frequencies. GMP inspections aim to ensure that the final product meets the quality criteria and specifications that are approved by the regulatory authorities, and that the manufacturing process is consistent and controlled. GLP inspections aim to ensure that the non-clinical studies are conducted in a scientific and ethical manner, and that the data are reliable and traceable. GMP inspections are usually performed before the product is approved for marketing, and then periodically or randomly after approval. GLP inspections are usually performed after the studies are completed, and then occasionally or on request.
To prepare for a GMP inspection, you should review your quality system, procedures, and records, and ensure that they are up to date, complete, and compliant with the GMP regulations and guidelines. You should also train your staff on the GMP expectations and requirements, and assign roles and responsibilities for the inspection. You should be ready to provide the inspectors with access to your facilities, equipment, documents, and samples, and to answer their questions and requests. You should also have a contingency plan in case of any deviations or non-conformities.
To prepare for a GLP inspection, you should review your study plans, protocols, reports, and records, and ensure that they are consistent, accurate, and compliant with the GLP principles and practices. You should also train your staff on the GLP standards and procedures, and assign roles and responsibilities for the inspection. You should be ready to provide the inspectors with access to your laboratory, equipment, documents, and specimens, and to answer their questions and requests. You should also have a corrective action plan in case of any findings or deficiencies.
GMP and GLP inspections are not only mandatory, but also beneficial for your organization. They can help you improve your quality system, identify and correct any gaps or weaknesses, and enhance your reputation and credibility. They can also help you avoid any regulatory actions, such as recalls, warnings, or sanctions, that could harm your business and customers. By following the GMP and GLP standards and practices, you can ensure that your products and studies are of high quality, safety, and efficacy, and that you meet the expectations and requirements of the regulatory authorities and the public.
Good Manufacturing practices and Good Laboratory practices shall be integral part of any pharmaceutical manufacturing, testing, distribution, storage facilities. It can't be distinguished gmp and glp in a pharmaceutical manufacturing facility, however can be distinguished in case of testing Laboratory alone. The credibility and reliability of manufacturing facility largely depends on how well the regulatory compliance is adhered, how well the departures of procedures and failure investigations are addressed, how effective are the Capa.