AmPharmCo Regulatory and Compliance

Quality Assurance reviews, approves and controls all specifications, manufacturing procedures, protocols and standard operating procedures (SOPs). All documentation related to each product lot is reviewed and released by qualified QA personnel.

AmPharmCo’s Quality Assurance Document Control Center maintains over 1,000 controlled documents including all SOPs, specification, protocols, approved master batch production records, and completed finished product records. Document Control issues all batch production records for each lot manufactured at AmPharmCo, reviews all finished batch production records according to CFR 21 Section 211.192, and issues release of each finished product lot for distribution.

The Regulatory Affairs Department at AmPharmCo obtains and maintains compliance with all local, state and federal regulations, including FDA registration, labeler code and drug product listing, labeling requirements, companion animal product regulations and all states registrations of companion animal nutritionals with the American Association of Feed Control Officials (AAFCO). Export dossiers are created and maintained for customers in other countries who wish to purchase private label products for distribution. Regulatory Affairs also obtains and maintains all permits, testing and periodic reporting for continued environmental compliance with local, state and federal environmental regulatory agencies.

The Director of Regulatory Affairs works closely with AmPharmCo’s contract manufacturing customers to ensure that the final product meets the highest quality standards possible and fulfills the customer’s expectations.