IPA- EDQM SYMPOSIUM 2007 REFERENCE STANDARD DEVELOPMENT -IP PERSPECTIVE

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

2. 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

3. 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

4. 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

5. 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 (?)

6. 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

7. 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

8. 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 !

9. Thank You