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 and the future Q11 to help ensure product quality throughout a product lifecycle, leading to continuous product improvement.
PQLI Technical Teams
PQLI Technical Teams are working groups addressing broad cutting edge regulatory & compliance issues that affect industry across dosage forms and in small and large molecules.
Blend Uniformity and Content Uniformity
The withdrawal of the FDA draft guidance document for the pharmaceutical industry, Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment document and lack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.
The ISPE Technical Team has developed tools, publications and FAQs on this topic. Learn More
- This team is engaging the industry and regulators for open discussion on the impact of Breakthrough Therapy designation on the Chemistry, Manufacturing and Control (CMC) part of a development project.
- An article published in the Jan/Feb 2015 issue of Pharmaceutical Engineering, CMC Considerations When a Drug Development Project is Assigned Breakthrough Therapy Status, discusses the impact on Chemistry, Manufacturing and Control (CMC) part of a development project when a project is assigned Breakthrough Therapy (BT) status as given in Food and Drug Administration Safety and Innovation Act (FDASIA) and FDA Guidance on Expedited Programs for Serious Conditions.
- ISPE held a Continuous Manufacturing Conference in April 2016, co-chaired by FDA, attended by industry professionals from 13 countries.
- A workshop was held in June 2018 in Arlington, Virginia.
- A Special Report was published in the May/June 2017 issue of Pharmaceutical Engineering.
- This working group is developing papers for how regulatory and CGMP compliance implementation could be accomplished.
- Related Pharmaceutical Engineering articles:
- Related iSpeak blog posts:
- ISPE’s Knowledge Management Technical Team is developing a body of knowledge around the practice of knowledge management for the pharmaceutical industry.
- Related discussion papers:
- ISPE’s Process Capability Technical Team is developing guidance for industry regarding effective use of process capability measurements. Three work streams:
- Maturity Model
- Compliance vs Performance
- Related Pharmaceutical Engineering articles
- ISPE’s Process Validation Technical Team develops discussion papers, training courses, and continuing education conferences.
- In 2017, ISPE held the Process Validation and Process Validation Statistic Conferences in Bethesda, MD. View the global calendar to find future Process Validation and Process Validation Statistics events.
- ISPE training courses are available in the topics:
- Several discussion papers have been developed. View Discussion Papers
- Related Pharmaceutical Engineering articles:
- Related iSpeak Blog posts:
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.
For more information, contact RegulatoryAffairs@ISPE.org.