GMP Assessment and Certification Program Terms
Scope, criteria, methodology and private nature of the certificate of the Access FDA GMP Assessment & Certification Program.
Draft pending legal review. This text is not yet the final, binding version.
The program
The Access FDA GMP Assessment & Certification Program (“the Program”) assesses a facility against good manufacturing practice criteria defined on the basis of applicable regulation; for example, 21 CFR Part 117 (food), 21 CFR Part 111 (dietary supplements), FDA guidance on cosmetic GMP, or 21 CFR Parts 210 and 211 (OTC drugs), as applicable.
Scope, criteria and methodology
Before starting, Access FDA and the Client agree in writing on:
- the facility, lines and processes included;
- the applicable regulatory criteria;
- the methodology (on-site, remote or combined assessment; document review; interviews and record sampling);
- the deliverables and schedule.
Depending on the accepted proposal, the Program may include gap assessment, action plan, development of standard operating procedures (SOPs), quality systems, training, internal audits and mock inspections.
Nature of the certificate
GMP certifications, attestations or recognitions issued by Access FDA are private documents based on the evaluation scope, regulatory criteria and methodology defined for the contracted service. Unless expressly stated and supported by official documentation, such certifications do not constitute a certification issued, approved or sponsored by FDA.
In addition:
- the certificate belongs exclusively to the facility and scope assessed;
- it may not be assigned, resold, modified or presented for another entity or facility;
- it states its private nature, its scope and its date;
- it reflects the condition of the facility at the time of the assessment and does not replace inspections by the authorities.
[Pending: validity of the certificate and follow-up or reassessment conditions.]
Client obligations
The Client provides access to the facility, staff and necessary records, provides truthful information and implements the agreed corrective actions. If the facility does not meet the Program criteria, Access FDA does not issue the certificate and identifies the remaining gaps.
Limits
The Program does not promise results in FDA inspections, product approval or acceptance by buyers. The Program’s commercial name does not authorize presenting it as a certification issued or sponsored by the FDA.
Payments
The General Terms of Service and the accepted proposal apply. Travel and on-site work are quoted per project.