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.
At the request of FDA and under the sponsorship of ISPE’s PQLI group, an ISPE Quality Metrics working group has delivered a whitepaper to FDA identifying potential quality metrics acceptable to industry in support of risk-based inspections as called for in the US Food and Drug Administration Safety and Innovation Act (FDASIA). The recommendations contained in the paper stem from robust industry - FDA discussions facilitated by ISPE.
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 email@example.com.