Focus on Standardisation, Quality by Design and Regulatory GMP - Pharmaceutical Technology

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Focus on Standardisation, Quality by Design and Regulatory GMP
June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.

Pharmaceutical Technology Europe
Volume 23, Issue 11

PDA: focus on QbD

The PDA held its first Single-Use Workshop in Bethesda on 22–23 June. The main focus was to preview the draft PDA Technical Report on Single-use Manufacturing, which is currently in development, and to solicit attendee feedback. As a member of the PDA Single-use Task Force, I served on the Planning Committee and as a moderator and presenter on the report for this workshop.

The purpose of the new report is to provide the reader with critical concepts and topics to consider when implementing a single-use manufacturing strategy for drug or vaccine production. The draft report discusses single-use systems that may be in direct or indirect contact with raw materials, intermediates, intermediate products, pharmaceutical drug substances or the drug product. The primary goals for developing a single-use manufacturing strategy are customer-based and focus on patient safety and product availability, as well as product and process understanding and control.

The workshop programme focused on QbD principles and other high-level topics to guide users on their initial decision, selection, validation and implementation of single-use processes. The workshop included several opportunities for Q&A and open discussion, which gave the task force valuable feedback from attendees on the draft report. Key take-away points included:
  • The report should aim to help end-users move away from gut-feeling to fact-based decisions.
  • Control of suppliers will come under more scrutiny and supplier audits can be expected to increase.
  • More detail on materials and manufacturing methods (e.g., films) may be required.
  • Partnership between the supplier and end user was stressed; those companies that truly embrace partnership will be the ones most likely to achieve success.
  • The industry will expect suppliers to have pharmaceutical standard quality systems in place, particularly with regards to having an appropriate materials change control and change notification programme.
  • Training in single-use will also be a key requirement/capability from suppliers.

Clear communication strategies encompassing quality, trust, track record, openness and security will be in focus.

The target date for the report's publication is by the end of this calendar year. Current activities entail completion of the manuscript incorporating the feedback from the June workshop and final technical review of completed sections. Follow-on workshops are planned for Uppsala (Sweden) on 28 November 2011 and Phoenix (AZ, USA) on 18–19 April 2012 (see for details).


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