Product Quality Lifecycle Implementation (PQLI) ®

ISPE’s Product Quality Lifecycle Implementation (PQLI)^® initiative was created to provide guidance on practical implementation of the concepts described in ICH guidelines, focusing on ICH Q8, Q9, Q10, Q11 and Q12 to help ensure product quality throughout a product lifecycle, leading to continuous product improvement. The original project produced the ISPE PQLI^® Guide Series.

PQLI Guides

Articles and Blogs

• PQLI: Advancing Innovation & Regulation
• PQLI Application of Science-and Sisk-based Approaches (ICHQ8,Q9,andQ10) to Existing Products
• PQLI Design Space
• PQLI Roadmap: Product Design, Development, and Realization, Science- and Risk-Approach to Implementation

Training Course

• Turning Quality by Design (QbD) into a Practical Reality

Current PQLI Teams

Today, PQLI Technical Teams are developing solutions in emerging regulatory and scientific topics related to CMC and GMP approaches to ensuring product quality.

• Accelerated Development & Manufacturing

  Uncovering the ambitious strategies or non-standard approaches that have been successful for accelerated products.

  Publications by the team:

  • Accelerated Pharma Product Development, Registration, Commercialization & Life Cycle, Part 1
  • Accelerated Pharmaceutical: Product Development, Registration, Commercialization, & Life Cycle CMC Lessons, Part 2
  • CMC Considerations When a Drug Development Project is Assigned Breakthrough Therapy Status

• Analytical Method Strategy / ICH Q2(R2), Q14

  Helping to shape the guidelines and training materials, helping industry prepare for their implementation.

  Publications by the team:

  • Readiness for Implementation of ICH Q2(R2) and Q14 Industry Survey Results
  • Streamlining Post-Approval Changes Industry Insights on ICH Q14
  • Streamlining Analytical Procedure Development, Validation, and Change Management: ICH Introduces Q2(R2) and Q14 Guidelines
  • Industry Perspectives on Practical Application of Platform Analytical Procedures
  • ICH Q2(R2) & Q14 Aim to Promote More Robust Analytical Processes, Greater Ease for Switching Analytical Methods Post Approval
  • Related comments: ISPE comments on CH Q2 (R2): Validation of Analytical Procedures
  • Related comments: ICH Q14: Analytical Procedure Development

• ICH M4Q(R2)

  Related comments: ISPE Comments on Comments on ICH M4Q(R2) Guideline on the Common Technical Document for the registration of pharmaceuticals for human use: Quality

• ICH Q12 Implementation

  Aiding industry and regulators in the adoption of Q12 tools globally.

  Publications by the team:

  • ISPE Members Continue Training Health Authorities on ICH Q12 Implementation
  • ICH Q12: A Transformational Product Life-Cycle Management Guideline
  • ICH Q12 Implementation Strategies Discussed During Webinar on Challenges and Success of ICH Q12
  • A Vision for ICH Q12: Current Experience, Future Perspectives
  • ISPE Assists Health Canada with ICH Q12 Training
  • Webinar: Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12
  • Webinar: Challenges & Successes of ICH Q12 Related Submissions
  • Related: ISPE Comments on FDA ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management

• Quality Risk Management ICH Q9(R1)

  Providing industry input and training materials to the ICH Q9(R1)EWG.

  Publications by the team:

  • ISPE Members Help Prepare Industry to Implement ICH Q9 Revision
  • Quality Risk Management: Ensuring Shared Responsibility across Key Stakeholders
  • Expert Xchange: Regulatory Summit on ICH Q9 Revision
  • Related: ISPE Comments on Guideline Q9(R1) on Quality Risk Management, Step 2b

• Science- and Risk-based Specifications / ICH Q6

  Progressing a science and risk-based approach to setting specification acceptance criteria for global commercial products.

  Publications by the team:

  • Establishing Patient Centric Specifications for Drug Substance and Drug Product Impurities
  • Patient-Centric Specifications from an Industry and Regulatory Perspective
  • Patient-Centric Specification: Regulatory & Pharma Industry Progress
  • Webinar: Patient-Centric Specifications from an Industry and Regulatory Perspective

• Stability / ICH Q1

  Provide expert insights and recommendations to enhance the quality and applicability of the guidelines. Facilitate collaboration and knowledge sharing industry professionals to address common challenges and improve regulatory compliance.

  Related comments: ISPE Comments on ICH Q1: Stability Testing of Drug Substances

• Transportable/POC Manufacturing

  Supporting European/US harmonization efforts regarding decentralized vs. distributed manufacturing paradigm

  Publications by the team:

  • Mobile Manufacturing in Pharma Promise, Progress, and Practicalities
  • Update on Transportable and Point of Care Manufacturing
  • Transportable Manufacturing
  • Transportable, Small Footprint Biopharmaceutical Manufacturing Facilities: A Regulatory Perspective
  • Webinar: Regulatory Opportunities and Challenges for Portable Manufacturing
  • Related: ISPE Comments on Distributed Manufacturing and Point-of-Care Manufacturing of Drugs Discussion Paper
  • Related:  ISPE Comments on MHRA Consultation on Point of Care Manufacturing

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