Good Manufacturing Practices Working Group

Working Group Members USA: Molzon Justina: Coordinator ARG: Rodolfo Mochetto BRA: Suzana Machado Marcelo Vogler de Moraes MEX: Sonia Zamudio Alonso CHI: Magdalena Reyes GUT: Norma de Pinto CAN: Louise Jodoin VEN: Elsa Castejón FIFARMA: Anthony Ventura ALIFAR: Marisela Benaim Resource Persons: Millie Barber/Arlene Badillo PAHO : Rosario D’Alessio >> Juanita Rodriguez

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 — 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

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

IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic 2-4 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 for Verification 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

Proposals to the Conference

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 for Verification of GMP The proposed Decision Tree includes –Quality Assurance –Critical Supporting System –Validation and facilities

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

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

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