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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

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Ipa edqm symposium 2007 reference standard development ip perspective l.jpg

IPA- EDQM SYMPOSIUM 2007REFERENCE STANDARD DEVELOPMENT -IP PERSPECTIVE

A.R Gomes – Sr.Director, Quality Control

Dr.Reddy’s Laboratories.


Ip reference standards changing times l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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 flow6 l.jpg
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 flow7 l.jpg
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


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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 !



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