cGMP · Current Good Manufacturing Practice

cGMP Compliance Current Good Manufacturing Practice

cGMP — Current Good Manufacturing Practice — is the system of regulations enforced by agencies such as the US FDA to ensure pharmaceuticals, biotechnology products, food and medical devices are consistently produced and controlled. “Current” means using up-to-date technologies and systems, not outdated methods.

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Technicians in cleanroom suits operating pharmaceutical manufacturing equipment

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

In general

Quality assured in every batch

cGMP keeps facilities at high environmental standards with robust data integrity, significantly reducing the risk of contamination and production errors. For drug products in the US, the core requirements sit in 21 CFR Parts 210 and 211.

Full compliance with national and international regulatory requirements
Implementable in organizations of any size, including multi-site setups
Identification and control of risks in products and processes
Consistent quality and safety throughout the production life cycle
Ongoing improvement and operational efficiency

How it works

Your path to cGMP compliance

01Service agreementThe engagement begins with a signed agreement and a dedicated project team.
02Gap analysisWe assess your current practices against cGMP 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

cGMP service packages

A01DocumentationcGMP policies, SOPs, batch records and documentation — templates or fully customized.
B02ImplementationcGMP implementation support and expert consultation for your facility and team.
C03Internal auditInternal audit services and mock inspections for cGMP compliance.
D04Audit coordinationIndependent cGMP audit coordination via accredited certification bodies.
E05Full-service packageDocumentation, implementation, training, internal audit and certification coordination.

FAQ

cGMP frequently asked questions

01Does the FDA “certify” cGMP compliance?

No. The FDA inspects facilities for cGMP compliance rather than issuing certificates. Third-party cGMP audits and certificates demonstrate readiness to customers and partners and prepare you for FDA inspection.

02When should a pharma startup start on cGMP?

Before clinical manufacturing. Phase-appropriate cGMP — right-sized controls that scale with development — avoids costly remediation later and keeps investor and partner due-diligence smooth.

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