ISPE THAILAND WORKSHOP 2015
“Preparing for the new PIC/s GMP Annex 15”
Process Development, Process Validation and QbD - How to Manage the Requirements of the New EU/PICS Annex 15
Date: Tuesdayy 25th - Wednesday 26th May 2015
Venue: Ambassador Hotel Bangkok
Background and objective:
Here in Asian Region we have to follow PICS regulations, EU /PICS annex 15 states the following:
Process Validation should be based on documented critical process parameters (CPP’s) and critical quality attributes (CQA’s) as a result of risk assessment activities as applicable. If a design space justification is used, the process knowledge and statistics used to confirm a state of control should be available. Validation batches (including continuous process verification) that are released to the market should fully comply with GMP & Marketing Authorisation and meet all validation acceptance criteria.
What do companies need to do to comply with this?
• What companies need to know, overview including regulatory review USA, EU, Asian, and requirements of new PICS GMP Annex 15 for process validation
• Process understanding, CQA, CPP
• Development of acceptable operation range
• Required statistical processes
• Practical application of the ideas-Case Study on generic product
• Review of past records to determine CPP-Case Study (focus)
• Can Continuous Process Verification be developed for existing products?
• Company organization required
Mr. Bikash Chatterjee, Project Executive, Pharmatech Associates, Inc.
Further information: Agenda and Registration Form