IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic 2-4 March 2005

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IV Pan American Conference on Drug Regulatory
Harmonization Dominican Republic2-4 March 2005

• Report of the GMP
• Working Group
• Justina A. Molzon
• CDER/U.S. FDA

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Report of the GMPWorking Group

• Background
• Meetings
• Activities
• Accomplishments
• Proposal
• Adopt Document
• Requests
• National Drug Regulatory Authorities
• Pharmaceutical Industry
• National Universities
• PANDRH and members of Working Group

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PANDRH Steering Committee Priorities

• Urgent Issues
• GMP (FDA)
• BA/BE (FDA)
• GCP (ANMAT)
• Counterfeit (ANVISA)

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GMP Working Group

• USA Molzon Justina Coordinator
• ARG Rodolfo Monchetto /Carlos Chiale
• BRA Suzana Machado/Antonio Becerra
• MEX Saleta García
• CHI Magdalena Reyes
• GUT Jose Luis Aguilar, Norma de Pinto
• CAN France Dansereau
• VEN Elsa Castejón
• FIFARMA Marco Vega (AlternoMarisela Poot )
• ALIFAR Marisela Benaim (Alterno Miguel Maito)
• Resource Persons Millie Barber, Rebeca Rodriguez
  (FDA)

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GMPWorking Group Meetings

• March 3-4, 2002Caracas
• III Conference April 24-26, 2002
• May 5-7 2003Mexico City
• May 5-7, 2004Antigua, Guatemala
• Aug 30-Sept 1, 2004Dom Republic

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1st Meeting of theGMP Working Group

• Mission
• To promote the knowledge and implementation of
  GMPs as a strategy for improving the quality of
  medications in the countries of the Americas

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Prioritized Objectives

• Through individual and collective exercises the
  participants proposed for the GMP/WG the
  following objectives, listed in order of priority
• KnowledgeEducation/Training
• Development of a harmonized Guideline for GMP
  inspection
• Support to Regulatory Authorities

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2nd Meeting Topics for Discussion

• 3rd Pan-American Conference recommendations and
  decisions
• Guide for inspection of GMP
• Strategies to implement GMP inspection guide
• Responsibilities of the group
• Selection of Countries
• Inspectors and places for the test pilot
• Education/training activities
• Strategies for the second round of courses

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GMP Inspection Guide

• Guide drafted by ANMAT
• Follows WHO GMP 92
• 12 chapters/areas of focus
• WG proposed additional language and revisions to
  be incorporated into Guide
• Integrated WG recommendations

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Pilot to Validate GMP Inspection Guideline  

• Took place in November 2003
• Draft report distributed to the WG/GMP for review
  
• The team considered that the site for the pilot
  did not represent the average drug manufacturer
  in Latin America
• As a consequence, it was suggested that some
  members test the guideline as part of the pilot
  for validation in any drug manufacturer that is
  willing to cooperate with the process

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Guideline Implementation

• Selected members of the Group were requested to
  implement the Guideline in their country and send
  the Secretariat their results and
  recommendations.
• Proposed Plan
• Venezuela and ALIFAR Mexico and FIFARMA
• Need to involve the industry and the two members
  that are in the same country, to facilitate the
  test.  
• Results to be sent to Secretariat by 1 MARCH 04
• Waiting to hear from each team

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Comments on Guideline

• Comments on Guide at national level
• Guatemala reviewed the Guideline and submitted
  comments
• Comments were useful to the group
• Chile may also conduct a similar activity  

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Educational Seminars on GMP

• WHO modules on Validation, Water and Air Systems
  have been translated into Spanish and to be
  posted on the web
• These modules were implemented at a workshop held
  in Argentina for MERCOSUR countries.
• A national seminar on Validation held in Antigua
  prior to the meeting of the 3rd WG meeting
• Plans for national seminars for on specific
  aspects of GMP will be developed by the WG

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3rd and 4th Meetings of the GMP Working Group

• Continued to review, discuss and edit the
  document
• The WG members devoted themselves to finishing
  the document so that it could be presented at the
  Fourth Conference

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(No Transcript)
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Proposals and Requests

• Adopt the document
• Requests
• National Drug Regulatory Authorities
• Pharmaceutical industry
• National Universities
• PANDRH and members of the WG

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Proposal

• Taking into account recommendations made at the
  previous Conferences, the GMP WG, through the
  Networks Steering Committee, requests that the
  Fourth Pan American Conference on Drug Regulatory
  Harmonization
• Adopt the document Guideline for Verification of
  Good Manufacturing Practices for the
  Pharmaceutical Industry

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Requests to National Drug Authorities

• To verify that the national GMP regulatory
  framework contain but not necessarily limit
  itself to what is included in the Guideline for
  Verification of GMP for the pharmaceutical
  industry proposed by the Conference

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Requests to National Drug Authorities

• To develop a national plan of implementation
  (compliance) of the aspects set out in the
  Guideline for Verification of GMP through public
  hearings and national needs
• To promote, within the processes of harmonization
  of the subregional integration groups, the
  adoption of the Guideline for Verification of
  GMP proposed by the PARF Network

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Requests to Pharmaceutical Industry

• To make all the necessary efforts to implement
  GMP as required in the Guideline for Verification
  of GMP according to the plan of implementation
  approved by the Regulatory Authority

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Request toNational Universities

• To promote at pharmacy schools the adoption of
  training modules on GMPs and the Guideline for
  Verification of GMP in curricula for
  undergraduate students, and in continuing
  education courses

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Requests to PANDRH and Members of the GMP WG

• To continue to support the development of
  training programs in GMPs for inspectors and the
  pharmaceutical industry, primarily in the use and
  application of the Guideline for Verification of
  GMP and of other specific aspects of GMP
  interest, in accordance with a regional plan
  approved by the Steering Committee of the PANDRH

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Requests to PANDRH and Members of the GMP WG

• To include in the WG work plans direct advisory
  services to the countries that commit to adopting
  the Guideline for Verification of GMP
• 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
• To request that the WG prepare a report on
  activities associated with training programs and
  advisory services and to present said report at
  the next Pan American Conference on Drug
  Regulatory Harmonization

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Muchas graciasMuito obrigadaMerci

• Thank you