Compliance Audits | cGMP and GMP| ANAB

FDA GMP and cGMP Compliance Audits

ANAB now offers compliance audits to cGMP and GMP requirements. Because many cGMP/GMP requirements are included in ISO/IEC 17025 and ISO Guide 34, it is convenient to audit the elements not included and supply you with a certificate of compliance. These requirements are the same as those used by FDA to assess companies and include 21 CFR210 and 21 CFR211.

Current Good Manufacturing Practices (cGMP) Audits

These audits help to ensure quality through assessment of best practices relating to methods, equipment, facilities, and product controls, specifically in regulated industries-food and food packaging, dietary supplements, pharmaceuticals, medical devices, and cosmetics.

General GMP (Factory Quality and Capability) Audits

These audits determine whether products being manufactured will be safe and reliable, and are intended for non-regulated industries-such as toy, toy premiums, textile, personal care, household chemicals, and general consumer merchandise. Based on ISO principles, general GMP audits also assess whether production volume and schedules will be met, offering early detection of problems that could result in product defects, production delays, and other issues.

Please note: These assessments will not replace full FDA acceptance. Our certificate of compliance is intended for those who need to show a certificate of compliance to these specific requirements.

For more information, contact Roger Muse,