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:

  • 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

• Continuous Manufacturing

  Improving quality assurance and pharmaceutical development, registration, manufacturing and controls that can support convergence and harmonization following the approval of ICH Q13.

  Publications by the team:

  • Continuous Manufacturing as a Tool for Accelerated Development
  • Contrasting Drug Substance and Drug Product Continuous Manufacturing
  • Holistic Control Strategies for Continuous Manufacturing
  • Quality & Regulatory Solutions for PAT in Continuous Manufacturing
  • Opportunities in Continuous Manufacturing of Large Molecules
  • Regulatory Aspects of Global Acceptance of Continuous Manufacturing
  • Taking the Pulse of Emerging Technology in Continuous Manufacturing
  • Expert Xchange: Next Decade of Continuous Manufacturing
  • Related comments: ISPE Comments on ICH guideline Q13 on continuous manufacturing

• 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

• 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

• Patient Centric Specifications

  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

• Process Validation

  Assisting industry with technical challenges related to application to particular product platforms, stages in the product lifecycle and emerging technologies.

  Publications by the team:

  • Good Practice Guide: Process Validation
  • Process Validation Lifecycle for Packaging Oral Solid Dosage Forms
  • Process Validation in Context of Small Molecule DS and DP Continuous Mfg Processes
  • Overview of Packaging Validation for Drug Products
  • Process Validation Lifecycle Implementation for Existing Products
  • Determining Number of Process Performance Qualification Batches Using Statistical Tools
  • Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations
  • Impact of Statistical Tools on Process Performance Qualification
  • Lifecycle Approach to Biotech Process Validation
  • Stage 2 Process Validation: Process Performance Qualification Batches
  • Stage 3 Process Validation: Applying Continued Process Verification Expectations
  • Training course: Practical Implementation of Process Validation Lifecycle Approach
  • Training course: Process Validation Biotechnology Manufacturing Training Course
  • Webinar: Process Validation: Stage 1 - Process Design
  • Webinar: Process Validation: Stage 2 - Process Performance Qualification or Process Validation
  • Webinar: Process Validation: Stage 3 - Continued Process Verification or Ongoing Process Verification

• Stability/ICH Q1,Q5C

  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.

• Transportable/POC Manufacturing

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

  Publications by the team:

  • 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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