GMP · Good Manufacturing Practice

GMP Compliance Good Manufacturing Practice

Good Manufacturing Practice (GMP) is a system of guidelines ensuring products — particularly pharmaceuticals, food, cosmetics and medical devices — are consistently produced and controlled to established quality standards, covering processes, quality control, hygiene, equipment, documentation and staff training.

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Customer browsing pharmacy and cosmetics shelves

Standard: GMP
Typical timeline: 30–90 days
Outcome: Audit-ready compliance
Delivery: Remote & on-site, worldwide

In general

Preventing contamination, mix-ups and errors

GMP integrates requirements for both products and processes. Rigorous controls prevent contamination, mix-ups and errors, and harmonized expectations support international trade with the documentation bodies such as the FDA and EMA expect. For cosmetics, ISO 22716 is the internationally recognized GMP guideline.

Compliance with national and international manufacturing regulations
Suitable for single-site and multi-site operations of any size
Risk control within manufacturing to protect product quality and consumers
Continual improvement and operational efficiency
Consistent quality, safety and reliability throughout production

How it works

Your path to GMP compliance

01Service agreementThe engagement begins with a signed agreement and a dedicated project team.
02Gap analysisWe assess your current practices against GMP and prepare a detailed action plan.
03Documentation and implementationWe develop procedures and records, train your team and embed the system into daily operations.
04Internal auditA comprehensive internal audit confirms readiness and resolves any nonconformities.
05Certification auditAn accredited certification body audits and issues your verifiable certificate.

How we can help

GMP service packages

A01DocumentationGMP policies, procedures and records — templates or fully customized documents.
B02ImplementationGMP implementation support and expert guidance on the production floor.
C03Internal auditInternal audit services against the applicable GMP requirements.
D04Audit coordinationIndependent GMP audit coordination through accredited certification bodies.
E05Comprehensive packageDocumentation, implementation, training, internal audit and certification coordination.

FAQ

GMP frequently asked questions

01What is the difference between GMP and cGMP?

cGMP (current GMP) is the term used in US FDA regulations and stresses using up-to-date systems and technologies. GMP is the broader, internationally used term. The principles are the same; the regulatory context differs.

02Is ISO 22716 the GMP standard for cosmetics?

Yes. ISO 22716 provides GMP guidelines for cosmetics production, control, storage and shipment, and is referenced by the EU Cosmetics Regulation.

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