Pharmaceutical Microbiology

Good Laboratory Practice (GLP) & Good Manufacturing Practice (GMP)

Written by MicroDok

GOOD LABORATORY PRACTICE (GLP)

Good laboratory practice (GLP) or good laboratory practices (GLPs) are accepted methods used in industries or hospitals and even laboratories to carry out activities or operations in a laboratory in order to achieve the desired or expected results. GLP help to ensure safety at every stage of the production process or experimentation. More so, GLP principles help to achieve quality of the end result of a particular experimentation or production process. While GLP govern the processes applicable to non-clinical studies and testing, it does not in any way approves or govern all of the processes and principles involved in clinical studies and testing. What governs clinical testing and studies is Good Clinical Practices (GCP). Other regulations such as the Declaration of Helsinki as shall be seen later in this section also regulate clinical testing and studies.

According to World health Organization (WHO), Good manufacturing practice (GMP) or Good Manufacturing Practices (GMPs) is the aspect of quality assurance that ensures that medicinal products and other pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. GMP can also referred be referred to as current Good Manufacturing Practice (cGMP). More details on GMP are outlined in this section.

Good laboratory practices are not guidelines. They have the force of law which usually pass through the process of legislation or some policy development in order to guide and direct the entire process of an experiment or a production process so that adequate safety and quality will always be ensured at every stage of the process. GLP is part of the quality assurance that ensures that organizations (including but not to food, medical, pharmaceutical, beverage and other allied industries) consistently produce and control goods to a high quality standard while ensuring adequate safety measures and protection of the environment and the working staff in the facility.

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. However, GLP applies to many other non-pharmaceutical agents such as color additives, food additives, food contamination limits, food packaging, and medical devices.

GLP only applies to non-clinical studies and testing. It does not apply to clinical studies. This is extremely important because clinical studies are governed by Good Clinical Practices (GCP), the Declaration of Helsinki, and other regulations intended to protect human participant safety. Furthermore, much of the GLP structure depends on the roles and responsibilities of the Study Director, who is a single individual that is responsible for the oversight and execution of all aspects of the non-clinical study. Study Directors do not exist in the clinical study arena, thus GLP principles cannot be applied effectively in the clinical setting.

GLP is a quality management system, not a scientific management system. GLP defines a set of quality standards for study conduct, data collection, and results reporting. GLP does not define scientific standards. If a study follows GLP, then you can be reasonably sure that the reported results were collected as outlined in the study protocol; however, you cannot be sure that the study actually addresses the scientific hypothesis. GLP would ensure that someone follows the recipe or guidelines of the experiment exactly as it is written down; however, it does not assure you that the steps was good or that the resulting item will be accurate or of high quality.

A key component of the GLP system of quality standards is the idea of a Quality Assurance unit (QA). This QA unit is intended to be an independent group or individual that monitors the entire study conduct, analysis, and reporting. The purpose of QA is to verify that all written procedures are followed throughout the study. As an example, perhaps there is an SOP (standard operating procedure) that says that a senior pharmacokineticist for example, must review the results prior to finalization. The QA auditor will verify that this review occurred. Verification could be done by reviewing a signed document, reviewing an electronic signature, or even speaking directly with the reviewer. The QA auditor will ensure that the senior pharmacokineticist has adequate training (as defined by SOPs in the organization) to perform his or her duties. This quality audit permits confidence that procedures were followed. But again, this audit does not ensure that the procedures are of high quality, or that no errors are made in the analysis.

GOOD MANUFACTURING PRACTICE (GMP)

According to World health Organization (WHO), Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.

GMP regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.  This protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

GMP is also sometimes referred to as “cGMP“. The “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the GMP regulations. Systems and equipment used to prevent contamination, mixups, and errors, which may have been first-rate 20 years ago, may be less than adequate by current standards. And this is what the “lower case letter, c” in cGMP actually means. GMP regulations vary from country to country and from one continent to another. GMP guidance

WHO establishes the general approach to the quality control of biological medicines that include products such as vaccines, blood and blood products, antigens, cell and tissue therapies, biopharmaceutical products, and other products intended for human usage. More than 100 countries have incorporated the WHO GMP provisions into their national medicines laws, and many more countries have adopted its provisions and approach in defining their own national GMP requirements. The WHO GMP continues to be used as a basis for the WHO Certification Scheme and prequalification of vaccines for procurement by UN agencies.

SEE THE DOWNLOAD SECTION ON THIS WEBSITE FOR ‘WHO’ HANDBOOK ON GLP AND GMP PRACTICES AND GUIDELINES.

Source:

https://www.certara.com/2013/12/09/

https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp

https://www.who.int/biologicals/vaccines/good_manufacturing_practice/en/

https://microchemlab.com/information/what-difference-between-glp-and-gmp-laboratory-testing-regulations

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