Current Good Manufacturing Practices Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages,[1] cosmetics,[2] pharmaceutical products,[3] dietary supplements,[4] and medical devices.[5] These guidelines provide minimum requirements that a…
Good Laboratory Practice 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.[1][2] These principles…
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 for Human Use (ICH), and…
Standard Operating Procedure A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations.[1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.[citation needed] Some military services…
Computerized System Validation Computerized system validation (CSV) (Computerised system validation in European countries, and usually referred to as “Computer Systems Validation”) is the process of testing/validating/qualifying a regulated (e.g., US FDA 21 CFR Part 11[1]) computerized system to ensure that it…
ISO/IEC 27001 ISO/IEC 27001 is an international standard to manage information security. The standard was originally published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) in 2005,[1] revised in 2013,[2] and again most recently in 2022.[3] There are also numerous recognized national variants…
Software as a Service Software as a service (SaaS /sæs/[1]) is a cloud computing service model where the provider offers use of application software to a client and manages all needed physical and software resources.[2] Unlike other software delivery models, it separates “the possession and ownership of software from…
Platform as a Service Platform as a service (PaaS) or application platform as a service (aPaaS) or platform-based service is a cloud computing service model where users provision, instantiate, run and manage a modular bundle of a computing platform and applications, without the complexity of building and…
Infrastructure as a Service Infrastructure as a service (IaaS) is a cloud computing service model where a cloud services vendor provides computing resources such as storage, network, servers, and virtualization (which emulates computer hardware). This service frees users from maintaining their own data center,[1] but they must…