IPA- EDQM SYMPOSIUM 2007 REFERENCE STANDARD DEVELOPMENT -IP PERSPECTIVE A.R Gomes – Sr.Director, Quality Control Dr.Reddy’s Laboratories.

IP Reference Standards - changing times!!  Pharma business in India poised for great leap  IP 2007 – upgraded methods/monographs  First time monographs – many therapeutic areas  May assume leadership in herbals  Monograph’s dependency on RS – in the increase  Cost is not a deterrence for science – changing mindsets  Acceptability of IP in the region - availability of RS is essential.  Global acceptance – a rightful national ambition

IP RS – current challenges  Not as organized as others in the league  Thin catalogue – doesn’t have them all  Availability  Scientific rigor  Industry participation  Evaluation/ Characterization – public awareness  Logistics – supply chain  Lot continuance – evaluation

IP RS – suggested way forward!!  Well organized structure for RS program  Setting up well equipped and manned RS evaluation laboratories  Approval/ Accreditation of labs for RS certification  Advanced analytical techniques – Industry support  Establishing robust work flow from procurement, distribution till lot continuation evaluation.  Public awareness through general chapter in IP  Seeking and securing widespread industry participation

IP RS – feasible work flow  Arrive on a list of priority items (IP 2007 ref)  Procurement of candidate material from Industry  Processing/synthesis of impurities – national /industry labs  Establish systems for storage of candidate materials  Mechanism for preparing evaluation protocol  Identify collaborative labs (national/industry/regulatory)  Send samples and protocol for testing  For new materials – complete characterization and mass balance approach  For materials for which already well established RS available, then use them as primary for determining potency in addition to identity (?)

IP RS – feasible work flow  Sponsors data – usage policy should be available  Usage of industry analytical support on advanced test requirements  Collection and review of analytical data  Approval of data and label instructions  Packing of RS in suitable packs  Labeling and identification  Distribution  Cold chain, normal, special pack – SOP’s  Lot continuity study

IP RS – feasible work flow  Listing of available standards in catalogue/web  Creating accessibility – commercial and scientific  Liaison of RS and specific monographs to address issues  Training of scientific and supply chain staff  Utilizing IP committee for establishing scientific rigor  Customer complaint handling mechanism  Information to customers on status of lot  Partner with USP/EP for gaining expertise and mutual benefits of avoiding duplication and hence cut cost  Keeping neutral autonomy position

IP RS – Conclusion  The relevance and significant is more than ever  Integral to industry in its current growth  High obligation to the industry in its future outlook  Opportunity to play global lead in selected therapies  Industry if tapped rightly can significantly contribute to the program and raise standards  The quality and acceptability of IP can be achieved only through an excellent RS program  Participation in global standard setting exercises  Time is now !

Thank You 