Announces Field-Test of Its Advancing Pharmaceutical Quality Program
BETHESDA, Md. (PRWEB) June 05, 2018 -- The International Society of Pharmaceutical Engineering (ISPE) announced today 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 execution
• 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.
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.
For more information contact:
Maria Robertson
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1-301-364-9207
Email: mrobertson(at)ispe(dot)org
http://www.ISPE.org
Maria Robertson, ISPE, http://www.ISPE.org, +1 813-960-2105 Ext: 404, [email protected]
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