Transcription of Process Validation (PV)
{{id}} {{{paragraph}}}
Example: marketing
Process Validation (PV)
National Pharmaceutical Control Bureau MINISTRY OF HEALTH MALAYSIA Process Validation (PV) Overview on ASEAN Guideline on PV Requirements Centre for Product Registration National Pharmaceutical Control Bureau Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor DL: + (EXT8517) | F: + | WS : | 1 NPCB MOH Topics of the Session Validation Definition by ASEAN PV Guide Data Submission Requirement of Development Report of Validation Scheme of Validation Report Validation type/ approach on Retrospective Validation & Concurrent Validation control Overview on ASEAN Guideline on PV Requirements 2 NPCB MOH 1. Process Validation Definition by ASEAN PV Guide Nasyrah Amalina Binti Sarginan Generic Medicine Section, Product Registration Center Overview on ASEAN Guideline on PV Requirements 3 NPCB MOH 1. Process Validation Definition by ASEAN PV Guide Process Validation is a means of ensuring that manufacturing processes are capable of consistently producing a finished product of the required quality.
• Container-closure integrity • Sorption and leaching issues f) Microbial attributes of dosage form g) Compatibility of drug product with diluents or dosage device (e.g precipitation of drug substance in solution, sorption on injection vessels etc) throughout shelf life of drug product 17
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: