Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is a system of quality management ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use. GMP evidence includes GMP certificates (issued by national regulatory authorities confirming compliance), manufacturing facility inspection reports (FDA Form 483s, EU GMP inspection reports, WHO GMP assessment findings), quality management system documentation (ISO 9001 or 13485 quality manuals, standard operating procedures, change control records, management reviews), and stability and validation studies (product stability testing, process validation reports, cleaning validation, method validation). GMP is mandatory for pharmaceuticals, medical devices, food, cosmetics, and dietary supplements across all major markets.

GMP is a legal requirement for manufacturing pharmaceutical products, medical devices, cosmetics, food, and dietary supplements in virtually all regulated markets. Without GMP certification or demonstrated compliance, products cannot be legally manufactured or placed on the market. Regulatory inspections can occur at any time — an FDA or EU competent authority inspection finding significant GMP deviations can result in production suspension, import alerts, or product recalls. Beyond regulatory compliance, GMP certification is a prerequisite for most buyer qualification programmes in regulated industries — pharmaceutical companies, medical device manufacturers, and food producers will only source from GMP-certified suppliers.

GMP certificates are official documents issued by national regulatory authorities or accredited certification bodies confirming compliance with GMP standards — required for pharmaceutical, medical device, cosmetic, and food manufacturing authorisations. Manufacturing facility inspection reports document regulatory inspection findings including observations (FDA Form 483), GMP compliance status, and corrective actions required — the primary regulatory oversight mechanism for GMP compliance. Quality management system (QMS) documentation includes quality manuals, standard operating procedures, change control records, deviation reports, CAPA records, and management review minutes — the core operational evidence of GMP compliance. Stability and validation studies document product stability testing protocols and results, process validation reports, cleaning validation, and analytical method validation — technical evidence required for regulatory submissions and inspection readiness.

GMP certificates, QMS documents, validation reports, and inspection records are uploaded to Sustalium and linked to the relevant product and regulatory frameworks. Manufacturing compliance data links to pharmaceutical, medical device, cosmetic, and food safety regulatory frameworks. Sustalium tracks certificate expiry dates, inspection cycles, and validation review schedules — sending alerts before GMP certificates expire to prevent market access disruptions. For multi-site organisations, Sustalium provides a consolidated view of GMP compliance status across all manufacturing facilities, enabling proactive management of certification renewals and inspection readiness.

EU GMP Directive (2003/94/EC) and EU GMP Guidelines for pharmaceutical products require GMP compliance for all medicinal products manufactured in or imported into the EU. US FDA 21 CFR Part 210 and 211 require GMP compliance for pharmaceutical products, with FDA inspections to verify compliance. The EU Medical Device Regulation (MDR) and US FDA Quality System Regulation (21 CFR Part 820) require GMP-equivalent quality management systems for medical devices. The EU Cosmetics Regulation (EC 1223/2009) requires GMP compliance for cosmetic product manufacturing. The Food Safety Modernization Act (FSMA) Preventive Controls rule requires GMP-equivalent food safety practices. WHO GMP guidelines serve as the reference for pharmaceutical manufacturing in most non-EU, non-US markets. ISO 22716 (cosmetics GMP) and ISO 13485 (medical devices QMS) provide internationally recognised GMP frameworks.