The FDA Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality’s (OPQ) 2017 Annual Report provides a panoramic snapshot of the Pharmaceutical Industry and the regulatory and quality activities therein. Established in 2015, the OPQ consists of over 1,300 staff responsible for regulating the quality of human drugs marketed in the US, providing assessment, inspection, research, surveillance, and policy for product quality, facilities and manufacturing processes.
The Office oversees all human drug User Fee programs: new drugs and biologics, generics, and biosimilars, as well as over-the-counter drugs and compounded drug products, during the entire drug product lifecycle from development through postmarket. This is the first Annual Report generated by the OPQ.
The report touches on many of the OPQ’s Quality Initiatives for 2017 including: Emerging Technology, Operations for Facility Evaluations and Inspections, New Inspection Protocols, Aided Assessment and Structured Application, and Enhanced Core Work Functions.
The OPQ defines a quality drug product as one that is “free of contamination and defects and reproducibly delivers the therapeutic benefit claimed in the label,” with a goal to assure, “(e)very pharmaceutical drug product marketed in the U.S. has established identity, strength, purity, and other quality characteristics designed to ensure its safety and efficacy.”FDA OPQ Annual Report
The OPQ intends to release a 2018–2022 Strategic Plan sometime this year, adding, “(t)o this end, OPQ will strengthen its collaborative culture, promote availability of better medicines, elevate awareness and commitment to the importance of pharmaceutical quality, and strengthen partnerships and engage stakeholders. In doing so, OPQ will lead the push for a stronger commitment to pharmaceutical quality in the name of patients and consumers. Above all else, OPQ will continue to assure that safe, effective, quality drugs are available to the American public.”