Glossary
Also known as: CAPA
CAPA Governmental agencies, such as the FDA, are challenging companies on an increasingly regular basis with regards to their CAPA systems. This is done to help to ensure that deviations/non-conformance, product complaints, external and internal audit observations, annual product reviews, recommendations and regulatory issues are identified, fully investigated to their root cause and properly assessed and effectively remediated.
Also known as: GCP, GCPs
Good Clinical practice is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected
GCP also ensures that subjects are properly protected in clinical studies. Such studies should be based on good science, are well designed and properly analyzed and adhere to procedures that are properly undertaken and documented. Adherence to GCP is vital otherwise, subjects participating in the trials may be put at risk or the clinical trial data submitted may be rejected by health authorities and the scientific committee, if found to be unreliable. Also, the research credibility of the researcher and the research institution may be damaged. Only investigators with GCP training and certification should therefore be chosen by pharmaceutical or healthcare companies to ensure that the studies conducted conform to regulatory requirements.
Also known as: GLP, GLPs
Good Laboratory Practice refers to the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the development of quality and the validity of test data and to provide a tool to ensure a sound approach to the management of laboratory studies, including conduct, reporting and archiving. The GLP principles may be considered as a set of standards for ensuring the quality, reliability and integrity of studies, the reporting of verifiable conclusions and the traceability of data, especially as it relates to animal studies. The biggest difference between GLP and Non-GLP work is the type and amount of documentation.
The formal, regulatory, concept of GLP originated in the USA in the 1970s because of concerns about the validity of non-clinical safety data submitted to the Food and Drug Administration (FDA) in the context of New Drug Applications (NDA). The FDA put forth Proposed Regulations on GLP in 1976, with establishment of the Final Rule in June 1979 (21 CFR 58). The GLP regulations provide the basis for assurance that reports on studies submitted to FDA faithfully and completely reflect the experimental work carried out.
Good Manufacturing Practice
Also known as: GMP, GMPs
GMP refers to the Good Manufacturing Practice Regulations promulgated by the Food and Drug Administration (FDA). These regulations require that manufacturers, processors, and packagers of drugs, and medical devices 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, mix-ups, and errors. This in turn, 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 recall, seizure, fines, and jail time.
GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. GMP may also be expressed as “cGMP”. The “c” stands for “current,” the purpose of which is to remind manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation.
Also known as: ISO
ISO standards are based on international consensus among the experts in the field. Consensus, like technology, evolves and ISO takes account of both evolving technology and of evolving interests by requiring a periodic review of its standards at least every five years to decide whether they should be maintained, updated or withdrawn. In this way, ISO standards retain their position as the state of the art. The ISO standards are designed to be globally relevant technical agreements, providing the framework for compatible technology worldwide and thus, useful everywhere in the world.
Also known as: QA/QC
Quality Control is a system of routine technical activities that measure and control product quality. Examples of QC procedures include technical reviews, accuracy checks, and the use of approved standardized procedures.
Quality Assurance is a system of review and audit procedures. It is an independent, objective review to assess the effectiveness of the QC program and its quality, completeness, accuracy, and precision.
Quality Systems Regulation
Also known as: QS Regulation, QSR
The QSR is in Part 820 of Title 21 of the Code of Federal Regulations (CFR). This regulation covers quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records.
Also known as: SOP, SOPs
A Standard Operating Procedure (SOP) can be defined as a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result.
