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 Q8, Q9, Q10, Q11 and Q12 to help ensure product quality throughout a product lifecycle, leading to continuous product improvement.

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

Active Teams

Accelerated Development & Manufacturing

Recent pandemic experience has brought to light challenges and opportunities related to development and manufacturing of bio/pharmaceutical products on accelerated timelines.

Analytical Method Strategy / ICH Q2(R2), Q14

ICH Q2(R2) and Q14 will bring forward new and additional considerations related to development of analytical procedures, and validation approaches for both traditional and advanced analytical techniques.

Continuous Manufacturing

Focus: Improve quality assurance and pharmaceutical development, registration, manufacturing and controls that can support convergence and harmonization of global regulatory expectations for continuous manufacturing

Publications by the team:


Focus: Develop a body of knowledge around implementation of Q12.

Publications by the team:

  • Transformational ICH Q12 Product Lifecyle Management Guideline: Evolution to Adoption

Knowledge Management

Focus: Develop a body of knowledge around the practice of knowledge management for the pharmaceutical industry

Publications by the team:

Patient Centric Quality Standards

Focus: Develop new ways of thinking in setting drug substance and drug product specifications.

Publications by the team:

Process Validation

Publications by the team:

Training course developed by the team: Practical Implementation of Process Validation Lifecycle Approach

Past Teams

Blend Uniformity and Content Uniformity

Focus: The withdrawal of the FDA draft guidance document for the pharmaceutical industry, Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment document and lack of confidence in the results from USP <905> Uniformity of Dosage Units testing resulted in uncertainty for manufacturers, but also presented an opportunity for developing a modernized approach to enforcing the GMP requirements in this area.

Accelerated Programs for Patients

Focus: address challenges that chemistry, manufacturing, and control (CMC) development teams may encounter when a project is given accelerated development status.

Publications by the team:

Process Capability

Focus: develop an industry-specific maturity model that can help companies design a robust process-capability program and benchmark against their peers.

Publications by the team:

PQLI® Good Practice Guides

Good Practice Guides provide information on global solutions to implementation challenges of ICH guidances.

Supporting Case Studies and Documents

The PQLI Good Practice Guides reference other case studies and relevant documents in the public domain. Many thanks must be extended to the teams which produced these documents, names and company affiliations of members of these teams being available from the documents.

30 October 2009: A–Mab: A Case Study in Bioprocess Development, CMC Biotech Working Group, version 2.1
This is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and Q10 guidelines could be applied to product realisation programs for a biotechnology-derived monoclonal antibody.

March 2009: Quality Overall Summary, Sakura Tablet, English Mock Quality Overall Summary (QOS), P2, PMDA work group
This is an example of the relevant parts of a Quality Overall Summary for submission to Japan MHLW for a small molecule tablet manufactured by direct compression and developed using the science- and risk-based approach.

March 2008: Pharmaceutical Development Case Study: “ACE Tablets”, prepared by CMC-IM Working Group
Produced as a Development Report for a small molecule tablet developed using the science- and risk-based approach using roller compaction. It is intended to help guide FDA and the industry toward the “desired state” of pharmaceutical quality envisioned for the 21st Century.

January 2006: European Federation of Pharmaceutical Industries and Associations, Mock P2
Produced in as an example of the Pharmaceutical Development (P2) section of a regulatory submission using the science and risk-based approach. This document was produced to promote discussion within industry and between regulators and industry of a small molecule tablet developed using wet granulation.

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