IPA- EDQM SYMPOSIUM 2007

REFERENCE STANDARD DEVELOPMENT

-IP PERSPECTIVE

A.R Gomes – Sr.Director, Quality ControlDr.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 leagueThin 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