The Office of Pharmaceutical Quality (established by USFDA), this new office was established in January 2015 with a a mission to assure that quality medicines are available for the American public.
As stated in the OPQ FDA Website
OPQ combines non-enforcement-related drug quality work into one super-office, creating one quality voice and improving our oversight of quality throughout the lifecycle of a drug product. OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas – new drugs, generic drugs, and over-the-counter drugs.
This organizational structure, along with new processes and policies, supports our mission to ensure that safe, effective, high quality drugs are available for the American public.
The changes that established OPQ include the following offices:
- Realignment of functions and personnel from the Office of Pharmaceutical Science to OPQ
- Realignment of preapproval and surveillance inspection activities from the Office of Compliance (OC) to OPQ
- Realignment of inspection-related activities for bioequivalence/bioavailability and non-clinical studies from OC’s Office of Scientific Investigations to the Office of Translational Sciences
One of the OPQ projects is the New Inspection Protocol Project (NIPP). When implemented NIPP will establish a new paradigm for inspection and reports that will advance pharmaceutical quality. According the the OPQ Overview by FDA NIPP will provide:
- Standardized approach to inspection
- Data gathering to inform “quality intelligence” of sites
- Risk based and rule based process using expert questions
- Semi-quantitative scoring to allow for comparisons within and between sites
- More common inspection report structure
- Positive behaviors recognized and rewarded when facilities exceed basic compliance
The objective of NIPP is to expand the scope of regulatory inspection from merely identifying GMP violations, to assessing the scope of a company’s quality system and operations. NIPP is divided into three subgroups depending on the type of inspection these include:
- Pre-Approval Inspection Protocol(s) subgroup
- Surveillance Inspection Protocol(s) subgroup
- For Cause Inspection Protocol(s) subgroup
As stated by Woodcock (reported by Mezher, Raps, 2017, para 12) “Implementation has been slow … but we would like to get a very standardized inspection protocol that then we can harmonize internationally.”