In consideration of the current regulatory climate of FDA actions, including Warning Letters and FDA-483s (list of objectionable observations), against pharmaceutical drug substance (API) and drug product manufacturers, FD-AID, LLC has implemented its Quality Systems Certification™ program. FD-AID, LLC has announced that it commenced certification audits in January 2023. The Certificate of GMP Compliance may be awarded to pharmaceutical companies that received an on-site audit under dynamic operations. Those audits must conclude with zero (0) Major or Critical deficiencies observed. Quality Systems Certification™ certificates are awarded for any or all of the six Quality systems recognized by the FDA (quality, production, facilities/equipment, laboratory controls, materials, and packaging/labeling). Audits are performed by, or overseen by, at least one former FDA Investigator with subject matter expertise in the system(s) audited. If Major or Critical observations are noted during the audit, closure through the site’s CAPA procedures must be closed with evidence provided for review prior to awarding of the certificate. Companies can identify a specific system to be audited and are encouraged to include the option for third party review under their Internal Audit procedure. This program is anticipated to assist companies to proactively address quality deficiencies prior to an FDA inspection but may also be considered as a part of a remediation plan post-inspection. The kick-off for this program initiated on 18 Jan. 2023 in India and is anticipated to be extended to pharmaceutical companies in the U.S., Africa, Europe and Asia.

FD-AID is a pharmaceutical consulting agency founded by former FDA Investigator, DeVaughn Edwards and is composed of former FDA Investigators and pharmaceutical industry executives. In less than 3 years, FD-AID has performed over 100 projects in 9 countries.

http://fdaid.org