GMPregler

GMPregler, or Good Manufacturing Practice regulations, are a regulatory framework that governs the manufacture, processing, packaging, and testing of products to ensure consistent quality and safety. The term is commonly used across industries such as pharmaceuticals, foods, cosmetics, and medical devices, though the precise requirements vary by sector and jurisdiction. In Europe, GMP is defined by EU directives and implemented through national authorities, with guidelines published by the European Medicines Agency and Eur GMP. In the United States, GMP requirements are codified in the FDA regulations (for example, 21 CFR parts 210 and 211 for drugs). Global health organizations, including the World Health Organization, and the ICH provide harmonized guidelines to facilitate international commerce and oversight.

Core GMP requirements typically include: a quality management system and quality unit; qualified and trained personnel; suitable facilities and equipment; validated and controlled processes; robust documentation and batch records; supplier qualification and material controls; clean and controlled production environments; in-process controls; finished product testing and release; change control, deviation handling, and investigations; calibration and maintenance of equipment; cleaning validation; traceability, complaint handling, and recall procedures; and audits of suppliers and internal processes. Documentation and record-keeping are essential for traceability and accountability.

Enforcement is carried out by national authorities through inspections and licensing actions. Non-compliance can lead to product holds, recalls, fines, or loss of manufacturing licenses. While GMP principles are widely adopted, exact rules and routines vary by product category and country.