Focus on Standardization, Quality by Design, and Regulatory GMP - In this quarter's column, highlights from the IBC Single-use Applications meeting, the PDA Single-use Workshop, and the BioProcess sys

ADVERTISEMENT

Focus on Standardization, Quality by Design, and Regulatory GMP
In this quarter's column, highlights from the IBC Single-use Applications meeting, the PDA Single-use Workshop, and the BioProcess systems Alliance International Single-Use Summit are presented.


BioPharm International
Volume 24, Issue 11, pp. 23-26

PDA: FOCUS ON QBD

The PDA held its first Single-Use Workshop in Bethesda on June 22–23, 2011. 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 program 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 also 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 regard to having an appropriate materials change control and change notification program.
  • 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 Nov. 28, 2011 and Phoenix, AZ, on Apr. 18–19 2012 (see http://www.pda.org/ for details).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here