GMP Certifications
Manufacturers, importers and distributors of products under health surveillance must follow Good Practices. We lead the adaptation of the operation and the preparation for the certification inspection.
- Company stage
- Enable
The path to certification.
A sequence of audits and implementations that takes the operation from diagnosis to inspection and includes the maintenance after the certificate.
Pre-project audit
Where the company stands against the applicable Good Practice requirements.
- Operation assessment
- Non-conformity list
Adaptation project
Structuring the regulatory project to correct the non-conformities found.
- Adaptation plan
- Priorities and deadlines
Processes and procedures
Mapping of operating processes and implementation of the new procedures.
- Process mapping
- New procedures
- Team training
Internal audit
Verification and validation of the Good Practices implemented.
- Internal audit
- Corrective actions
Pre-inspection
A preliminary audit run along the lines of the certification inspection.
- Inspection simulation
- Final adjustments
Certification inspection
Support during the certification audit conducted by the authority or the certification body.
- Manufacturing
- Storage and distribution
Maintenance
After the certificate: planned renewal and follow-up of the Good Practices in place.
- Certificate renewal
- Good Practices follow-up
Other services for this stage.
- Company LicensingEnableAFE and AE at ANVISA, establishment registration with MAPA, and licences from health surveillance authorities, the Federal Police, the Army, environmental agencies and municipalities.
- Product RegistrationEnableClassification, dossier and notification or registration of domestic and imported products at ANVISA and MAPA.
- Compulsory Certification & Foreign MarketsEnableLiaison with certification bodies under the INMETRO and ANATEL schemes and in other compulsory certifications.
Common questions before you start.
What is the CBPF and who needs it?
The Good Manufacturing Practices certificate (CBPF) is issued by ANVISA after an inspection of the manufacturing site or, for medical devices, on the basis of an MDSAP audit report. For Class III and IV medical devices, for example, the registration is only granted with a valid CBPF; medicines and other products have their own rules.
How long is the CBPF valid?
For medical devices, two years, or four years for manufacturers certified under the MDSAP programme. Renewal must be planned so there is no gap without a certificate.
How do you prepare the company for the inspection?
With a diagnostic audit, an adaptation project for facilities and processes, a review of procedures and records, and a pre-inspection that simulates the authority’s visit, so the inspection finds the operation compliant.
Last updated: October 2026.
A Good Practices inspection on the horizon?
We start with the pre-project audit: it shows the distance between today’s operation and what the inspection will check.