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Good Manufacturing Practices Working Group

Good Manufacturing Practices Working Group.

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Good Manufacturing Practices Working Group

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  1. Good Manufacturing Practices Working Group

  2. Working Group MembersUSA: Molzon Justina: CoordinatorARG: Rodolfo Mochetto BRA: Suzana Machado Marcelo Vogler de MoraesMEX: Sonia Zamudio AlonsoCHI: Magdalena ReyesGUT: Norma de PintoCAN: Louise JodoinVEN: Elsa CastejónFIFARMA: Anthony VenturaALIFAR: Marisela Benaim Resource Persons: Millie Barber/ Arlene Badillo PAHO : Rosario D’Alessio >> Juanita Rodriguez

  3. GMP Working Group Meetings • March 3-4, 2002—Caracas • April 24-26, 2002 III Pan American Conference on Drug Regulatory Harmonization Washington, D.C • May 5-7 2003—Mexico City • May 5-7, 2004—Antigua, Guatemala • Aug 30-Sept 1, 2004—Dominican Republic • March 2-4, 2005 IV Pan American Conference on Drug Regulatory Harmonization--Dominican Republic • July 20-22, 2005—Washington DC • March 3-5, 2006—Rockville, MD

  4. Work Plan • III Pan American Conference on Drug Regulatory Harmonization • Washington, D.C • April 24-26, 2002 • Working Group meeting • Training program design • Implementation of training programs • Mechanism for monitoring GMP implementation • Identify GMP standards under development in other Forums (WHO and ICH) • Consider mechanisms for joint inspections

  5. IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic2-4 March 2005 • Adopted the document: Guideline for Verification of Good Manufacturing Practices for the Pharmaceutical Industry • WG to follow up on the adoption and evaluation of incorporating the Guideline forVerification of GMP in national regulations of the countries, and adoption of the Guideline by the subregional working groups • WG to prepare a report on activities associated with training programs and advisory services and to present at the next Pan American Conference on Drug Regulatory Harmonization

  6. Proposals to the Conference

  7. Decision Tree for Implementing the Guideline for GMP Inspections • The WG created a decision tree to promote the development of a national plan towards implementation of the Guideline for Verification of Good Manufacturing Practices for the Pharmaceutical Industry • The decision tree would help national regulators and also the pharmaceutical industry since they will also be implementing the Guideline forVerification of GMP • The proposed Decision Tree includes • Quality Assurance • Critical Supporting System • Validation and facilities

  8. Adoption of ICH Q7 • The WG GMP proposes the adoption of the ICH-Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) as a Guideline for GMPs for APIs in the Americas • The Secretariat reviewed the Spanish versions of Q-7 created by ANMAT and FDA • A final draft was created and posted on the PANDRH web page for public comment • The final version is presented to the Conference for adoption

  9. Code of Ethics • The WG GMP developed a model code of ethics • It can be used by an Agency as a whole or only for inspectors of GMP • It can be adopted or adapted by national agencies but the ideal is to have a Code of Ethics for the Region • It covers requirements of good conduct, behavior, communications with the industry, loyalty to the agency, anti-discrimination policy, development and conflict of interest • A final draft was posted on the PANDRH web page for public comment • Presented to the Conference for adoption

  10. Mutual Recognition of GMP Inspections • PANDRH should promote harmonized procedures and information exchange among countries of the Americas • A common guideline, educational opportunities and participation in joint inspections are essential for mutual recognition • Ultimate goal is to build trust among NRA to promote efficient use of resources • The WG proposes that the Conference explore mechanisms to promote mutual recognition

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