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The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.
Good clinical laboratory practice (GCLP) is a GxP guideline for laboratory samples from clinical studies. Good clinical practice (GCP) does not define requirements for laboratories and good laboratory practice (GLP) focusses on pre-clinical analyses and not on human samples from clinical trials. The Research Quality Association (RQA) suggested ...
Good clinical practice. In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals ...
In fact, such predefined protocols are an essential component of Good Laboratory Practice (GLP) [11] and Good Clinical Practice (GCP) [12] [13] regulations. Protocols written for use by a specific laboratory may incorporate or reference standard operating procedures (SOP) governing general practices required by the laboratory. A protocol may ...
Good Manufacturing Practices emerged in response to serious incidents of harm caused by contaminated, adulterated, or improperly manufactured products. Major incidents include: Elixir Sulfanilamide Incident, Thalidomide Incident, Cutter Incident, and Dalkon Shield Incident. These incidents resulted in hundreds of deaths, infections, and birth ...
Good documentation practice. Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various ...
A best practice is a method or technique that has been generally accepted as superior to alternatives because it tends to produce superior results. Best practices are used to achieve quality as an alternative to mandatory standards. Best practices can be based on self-assessment or benchmarking. [1] Best practice is a feature of accredited ...
Laboratory safety. Many laboratories contain significant risks, and the prevention of laboratory accidents requires great care and constant vigilance. [1][2] Examples of risk factors include high voltages, high and low pressures and temperatures, corrosive and toxic chemicals and chemical vapours, radiation, fire, explosions, and biohazards ...