Standard
GMP
Good Manufacturing Practice
Manufacturing rigour across pharmaceutical, cosmetic and nutraceutical operations.
Benefits
- Product quality assurance
- Regulatory alignment
- Batch traceability
- Contamination control
- Consumer safety
Requirements
- Facility & equipment qualification
- Documented procedures & records
- Personnel training & hygiene
- Materials & product control
- Deviation & CAPA
- Batch release & recall
Certification process
- 01Application & scope
- 02Auto eligibility & mandays
- 03Documented information review
- 04Stage 1 readiness audit
- 05Corrective actions
- 06Stage 2 audit
- 07Independent decision
- 08Certificate issued
- 09Annual surveillance
- 10Recertification (Year 3)
Frequently asked questions
- How long does certification take?Typically 6–12 weeks depending on scope, sites and readiness.
- Is the certificate globally recognised?Yes — under the IAF Multilateral Recognition Arrangement.
- Can we transfer an existing certificate?Yes — see /certification/transfer-certification.
- Do you provide the standard document?No — IREA does not distribute ISO standards; buy from ISO/national body.