Transcription of Stability – Regulatory Requirements
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Stability – Regulatory Requirements
J. B. Chemicals & Pharmaceuticals Copyright 2005 J. B. Chemicals Pvt. Regulatory RequirementsDr. Milind JoshiPresident - Global Regulatory ManagementStability Requirements in Drug Substances / Drug Products for Submission to Regulated / Unregulated MarketsJ. B. Chemicals & Pharmaceuticals Copyright 2005 J. B. Chemicals Pvt. Copyright 2005 J. B. Chemicals Pvt. B. Chemicals & Pharmaceuticals Retest Period / Shelf LifeMinimum Period till when the product Is safe to use Retains its quality Retains its efficacy For chemicals retest period For formulations shelf life (no reprocessing) Copyright 2005 J. B. Chemicals Pvt. B. Chemicals & Pharmaceuticals Ltd.<1191> Stability CONSIDERATIONS IN DISPENSING PRACTICEC riteria for Acceptable Levels of StabilityNo significant increase in toxicity therapeutic effect remains or resistance to microbial growth is retained according to the specified Requirements .
Title: Microsoft PowerPoint - StabilityReqmnts.ppt Author: admin Created Date: 5/27/2009 5:10:54 PM
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