FDA's Office of Pharmaceutical Quality gives an Overview of its Activities 2018

The Office of Pharmaceutical Quality (OPQ) was established in 2015 within the FDA as part of the Center for Drug Evaluation and Research (CDER). The aim was to ensure the quality of drugs throughout their entire lifecycle, from development to commercialisation. Composed of different subdivisions, the OPQ not only deals with research but also with inspections and market surveillance. The OPQ employs over 1,300 people and is thus the largest "office" within the CDER. The OPQ is also involved in the quality control of clinical trials (IND) and marketing authorisations for both classical drugs (NDA, ANDA) and biologics (BLA) and biosimilars. Now, the OPQ has reviewed the year 2018 and published a 13-pages report.

In 2018, the OPQ set the following strategic priorities:

  • "COLLABORATE: Strengthen OPQ's collaborative culture"
  • "INNOVATE: Promote availability of better medicines"
  • "COMMUNICATE: Elevate awareness and commitment to the importance of pharmaceutical quality"
  • "ENGAGE: Strengthen partnerships and engage stakeholders"

Regarding cooperation, the respective figures of authorisations are provided and the report also mentions that 15 domestic and 37 foreign inspections were carried out within the framework of the authorisation of biologics in 2018. As part of the strategic priority "Innovate", the report mentions the approval of two applications based on continuous manufacturing and one application for the endotoxin test with Recombinant Factor C. This method should help to reduce the need for horseshoe crab blood during testing. The "communicate" section focuses on a survey of patients' and consumers' knowledge of pharmaceutical quality. The section "Engage" refers to two new Quality Metrics programmes and further guidance published by the OPQ following stakeholder comments. Furthermore, the OPQ set up an "Experimental Learning Site Visit" programme in which OPQ staff learned elements of drug product development and manufacturing on-site. The OPQ was also a key participant in providing the New Inspection Protocol Project (NIPP). Within the framework of this project, electronically standardized inspection protocols will be generated to ensure more consistent inspections. The report also presents the progress made in the USA-EU MRA.

You can find the complete report on FDA's website.

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