GMP compliance is required by the FDA; however, GMP certification is not required by the FDA.

Occassionally the FDA will perform random audits to verify compliance, but these audits are rare. For this reason, buyers of your product will often want some kind of objective evidence that you are compliant. In order to provide this, you can have an independent third party auditor perform an audit and "certify" that you are compliant.

GMP certification often results in more customers because customers trust that you are compliant when you provide your GMP certificate.

GMP requirements apply to manufacturing facilities, but they also apply to other participants in the product supply chain, including contract manufacturers and storage and distribution companies.

Third party auditing companies are often called "certification bodies." Certification bodies audit against their own accredited gmp certification program and their own GMP standard. An applicant must meet their GMP program requirements in order to pass their audit.

Certify Consulting provides GMP consulting services and can help you achieve GMP compliance in order to pass a GMP audit or an FDA inspection. Our GMP certification consulting services include gap assessments, document drafting (including standard operating procedures, forms, and checklists), GMP Training, facility inspections, internal audits, and more.