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Field-Test of ISPE's Advancing Pharma Quality Program

Article - ISPE Pharmaceutical Engineering

ISPE announced at its 2018 ISPE Quality Manufacturing Conference that it is field-testing the design principles of a comprehensive industry-led program of self-evaluation of pharmaceutical quality program with industry colleagues, senior leaders, and regulators.

Mairead Goetz, Global Head Analytical Science and Technology, QC, OpEx, Chair of ISPE’s Advancing Pharmaceutical Quality (APQ) program, made the announcement during a special working group session.

The vision for the program is to evolve the focus from submission of harmonized quality metrics as given in recent FDA guidance documents to establishing a framework for advancing the state of pharmaceutical quality while at the same time continuing to align with the purpose outlined by FDA. ISPE believes this approach will deliver on the objectives outlined by FDA and will increase the value to industry.

The “assess and aspire” framework provides methodologies and examples of key performance/business indicators for self-analysis and benchmarking of quality maturity, based on integration of culture, quality, and operational excellence disciplines. Elements included in the framework are derived from ICH Q10, Pharmaceutical Quality System. An organization may then choose to aspire to make improvements using the methodologies suggested.

ISPE’s APQ program has established the following guiding principles:

  • Demonstrate value to industry, regulators, and patients
  • Industry for industry – at least at the outset
  • Voluntary
  • Be applicable across all sectors of the pharmaceutical industry
  • Use company data and sites procedures “as is” to the extent possible to minimize additional work
  • Leverage existing methodologies and program principles where relevant, e.g. ISO, VPP, MHRA, ICH Q10
  • Complement existing FDA initiatives (e.g. QM, NIPP, Data analytics)
  • Simple/Well defined assessment criteria
  • Phased Approach
  • Inclusion of Incentives/recognition

Goals of this program include:

  • Enable and foster industry ownership of quality beyond compliance
  • Integrate quality, cultural, and operational excellence principles and learnings
  • Support and incentivize continual improvement
  • Promote efficient use of resources by improving executionBe applicable across all sectors of the pharmaceutical industry
  • Increase reliability of supply of quality product
  • Fuel benchmarking, sharing, and learning among companies
  • Encourage self-improvement and supplier improvement
  • Have a potential competitive advantage

This program will use other similar programs such as the OSHA Voluntary Protection Program (VPP) as a basis with design elements to include:

  • Voluntary
  • Phased
  • Well-defined assessment criteria
  • Inclusion of incentives/recognition

An overarching aspiration is that regulators will provide input to the design and may incorporate framework elements and learnings into regulatory programs.