The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products).  The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back on what OPQ has accomplished since its inception in 2015, highlights its focus on driving pharmaceutical quality, and is augmented throughout with quick supporting facts and opinions.  While it is important to understand what OPQ has done and is currently doing, it may be more important to understand where OPQ is going next.  Discussed here are a few of the hints on long-term focus included in the report in the areas of OPQ’s defined priorities: Collaborate, Innovate, Communicate, and Engage.

Collaborate

OPQ has leveraged the use of integrated, multi-discipline teams to perform quality assessments; this approach has been used to drive product quality into the review process and coordinate review activities with inspectional activities.  OPQ intends to continue to improve and build efficiency in the FDA’s integrated teams by increasing consistency in work assignments and team composition in future.

Innovate

The Emerging Technology Program (ETP) was created by OPQ to provide an early interface with industry on novel technology prior to regulatory submission.  This program seeks to make innovative technology that positively impacts product quality (such as continuous manufacturing) more of a regular occurrence in applications.  As a result of this initiative, seven (7) approvals of applications that included continuous manufacturing have been granted between 2015 and 2019.

Knowledge-aided Assessment & Structured Application (KASA) is a review process innovation that OPQ has been working toward.  KASA promises to improve the efficiency, effectiveness, and consistency of quality reviews while building and maintaining FDA’s knowledge base of data.  A pilot program for some generic applications was started in 2019.

Communicate

OPQ intends to hold more free public “regulatory education” events like the one it held in October 2019, Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium (see here).  This forum along with CDER Small Business and Industry Assistance (SBIA) events (see here) are likely places for OPQ to continue the discussion with industry on pharmaceutical quality.

Engage

Look for the final version of the ICH Q12 Guidance on Lifecycle Management which OPQ, representing the FDA, worked with other international regulators to harmonize guidelines on what parts of an application can be changed without involving regulators and the framework for doing so.  The meeting to harmonize and finalize the guidelines was held in Singapore in November of 2019 and the Q12 Lifecycle Guidance is currently in Stage 4 of the ICH process; the Step 4 final draft and its annexes that are being recommended by the ICH Expert Working Group for adoption can be found here and here.

OPQ report also addressed mutual recognition that has expanded from an agreement between the European Union (and the UK separately) to include five (5) additional countries in 2019 that are capable of meeting US inspectional requirements.  With this expansion, it is possible that more of industry will begin to see mutual recognition in practice.  Thus far, only 25% of inspections outside of the US have been subject to mutual recognition.

These are a few items noted in OPQ’s report that industry will likely be looking to understand more fully in the months ahead:

  • In January 2020, twenty-five (25) new work units were created within OPQ as a result of structural reorganization of CDER’s New Drugs Regulatory Program. Will these changes optimize efficiency as intended?
  • What is OPQ’s definition of “mature quality systems” and how do they intend to measure it in order to incentivize it?
  • On March 23, 2020 the FDA will transition over 90 insulin and insulin analog, human growth hormone, pancreatic enzyme, and reproductive hormone products approved as NDAs to biological products approved as BLAs in order to open these products to development and submission via the biosimilar pathway. How will the transition, policies, and guidance play out in practice?

If you have any questions or are in need of services related to product quality, please reach out to Lachman Consultants at LCS@Lachmanconsultants.com.