Product Quality Lifecycle Implementation® (PQLI®) is ISPE’s Global Industry Initiative for a practical approach to implementation of International Conference on Harmonization (ICH) guidances Q8 (R2), Pharmaceutical Development; Q9, Quality Risk Management; Q10, Pharmaceutical Quality System; and Q11, Development and Manufacture of Drug Substances.
The Product Quality Lifecycle Implementation (PQLI) initiative resulted from the need to help industry find global solutions to implementation challenges of ICH guidances.
Results are immediate, practical, and applicable. PQLI products are targeted at a wide spectrum of multi-disciplinary professional levels representing all stages of the lifecycle.
PQLI is building a set of resources useful to a broad spectrum of companies:
ISPE welcomes input from all parties, yet its work products will not replicate activities underway by industry. For example please see information relating to our relationship with PDA and their Paradigm Change in Manufacturing Operations (PCMO™) program.
Product Quality Lifecycle Implementation® (PQLI®) Good Practice Guides (GPGs) provide information on global solutions to implementation challenges of ICH guidances.
Under the sponsorship of ISPE’s PQLI group and senior quality leaders from a range of innovator and generic companies, an ISPE Quality Met¬rics working group has been working to identify quality metrics acceptable to industry and reportable to the FDA in support of risk-based inspection as called for in the US Food and Drug Administration Safety and Innovation Act (FDASIA). As a first step toward producing a white paper to submit to FDA later in December 2013, the working group has released a status update to present ISPE’s latest thinking.
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.
Learn about this important initiative. A webinar about the basics of PQLI is available on demand - free to ISPE Members, US$49.00 for non members.
To contribute, learn more, reach a member of the PQLI team, or get involved with PQLI, please email us at firstname.lastname@example.org.