Good manufacturing conditions, or good maufacturing practice (GMP), in the pharma industry are designed to ensure that the pharmaceutical products are manufactured in accordance with the requirements of the factory quality system. Implementation of GMP will minimize risks associated with production processes. GMP covers all aspects of production, ranging from vendor or suppler certification, raw material acceptance and storage, cleanliness and production facility infrastructure and support systems, production equipment, employee conduct and training, and cleaning and validation processes.
In Israel, Ministry of Health audit and enforcement procedures are carried out to evaluate and enforce GMP requirements.
In the US, GMP requirements are described and enforced for drugs and medicines under 21 CFR parts 210 and 211, and for medical devices under 21 CRF 800.
In Europe, GMP requirements for drugs and medicinal products are described and enforced as part of Directive 2003/94/EC, and for medical devices under the Medical Device Directives and the 2017 Medical Device Regulations.
