文档介绍:GUIDELINE FOR
GOOD
MANUFACTURING
PRACTICES
INSPECTIONS
1
PAN AMERICAN NETWORK FOR DRUG REGULATORY HARMONIZATION
WORKING GROUP ON GOOD MANUFACTURING PRACTICES
MEMBERS*
Justina Molzon*, Associate Director for International Programs, FDA/USA. Group
Coordinator
Argentina: Carlos Chiale; Rodolfo Mocchetto*, Coordinator INAME/ANMAT
Brazil: Antonio Bezerra, Suzana Avila*, Inspección y Control de Medicamentos,
ANVISA
Canada: France Dasereau, Stephen McCaul; Louise Jodoin*, Inspection Unit, Health
Canada
Chile: Magadalena Reyes*, Inspector GMP. Instituto de Salud Pública (ISP)
Guatemala: Esmeralda Villagran; José Luis Aguilar; Norma de Pinto*, Jefe
Monitoreo y Vigilancia de Medicamentos, Ministerio de Salud
Mexico: Rosa María Morales, Suleta García*, COFEPRIS
Venezuela: Elsa Castejón*, Asesora Dirección de Drogas y Cosméticos, Ministerio
de Salud.
ALIFAR: Miguel Maito, Gerente Laboratorios Farmacéuticos Argentina; Marisela
Benaim*, CIFAR, Venezuela
FIFARMA, Marco Vega, QA/QC Manager, Lilly; Carmen Araujo, Laboratorios Elmor,
Marisela Poot,* GSK Regulatory Director
Resource Persons:
Rebecca Rodríguez, National Expert Drugs Investigator. FDA/USA
Millie Barber, International Programa Manger, FDA/USA
Secretariat
Rosario D’Alessio, PAHO/WHO
Juana M. De Rodriguez, PAHO-Guatemala
Miguel A. Lopez, PAHO-Venezuela
*Current members
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INTRODUCTION
This Guideline for Good Manufacturing Practices Inspection for the pharmaceutical
industry was prepared by the Working Group on Good Manufacturing Practices (WG/GMP), in
May 2003. The Guideline addresses the requirements of the WHO Technical Report on
Good Manufacturing Practices # 32 and the particular considerations of all me