Essential Medicines and Biologicals
Medicines and Health Technologies
Results of the activities of the Working Group on GLP
A. Documents prepared
- Red PARF Documento Técnico No. 2. OMS Serie de Informes Técnicos, No. 902, 2002. Informe 36, Anexo 3. Buenas prácticas para Laboratorios Nacionales de Control Farmacéutico. (2010) 137 p. (Spanish, English and Portuguese)
- Red PARF Documento Técnico No. 3. Guía de autoevaluación de buenas prácticas para Laboratorios Nacionales de Control Farmacéutico. (2010) 71 p. (Spanish, English and Portuguese)
Red PARF Documento Técnico No. 4. Estudio sobre las condiciones actuales de los Laboratorios Oficiales de Control de Calidad de Medicamentos (LOCM) en América Latina y el Caribe. (2010) 45 p. (Spanish, English and Portuguese)
Red PARF Documento Técnico No. 6. Documento de Autoevaluación de Buenas Prácticas de Laboratorio (BPL) (2011) 113 p. (Spanish, English and Portuguese)
The Pan American Network for Pharmaceutical Harmonization (PANDRH Network), through the Technical Working Group on GLP (WG/GLP), developed a proposal for a course on good practices for national pharmaceutical control laboratories. This course has been implemented in several countries of the Region. It will be presented at the Fifth Pan American Conference on Drug Regulatory Harmonization to be held in 2008.
- Promote use of the WHO recommendations for GLP: Report 36, Annex 3 (Technical Report Series 902, 2002).
- Improve the performance of the quality control laboratories.
- Circulate and promote use and correct implementation of the Self-Evaluation Guide on GLP of the PANDRH Network.
- Increase the communication and exchange of information between the official quality control laboratory, local manufacturers of medicines, and the academic sector.
- Update the knowledge of the staff members of the Ministries of Public Health and the academic sector with regard to the latest WHO recommendations on GLP.
3. Educational Materials
- Esquema de los curso BPL (1021 kB)-In Spanish
- General scheme for the GLP training workshop (2.34 MB)- In English
- Presentations: Work procedures module-In Spanish
- Workshops and solutions
4. Courses given
The team of instructors for each course consists of three professionals, a combination of university professors and professionals from pharmaceutical quality control laboratories. There are two basic criteria that should be met in all cases. All of the courses should have at least one facilitator from the university (teaching experience) and a facilitator from an official laboratory (practical experience). It is recommended that the facilitators should be from different countries, since this enriches the discussion of the subjects. They are usually from three different countries. In all cases, it is stressed that they should be from at least TWO different countries. A professional from the United States Pharmacopeia (USP) is also available to explain the proper use of the USP-NF and present a DVD on a commonly used technique (e.g., TLC, HPLC). The group of facilitators includes:
- Ruben Szyszkowsky (Universidad de Buenos Aires, Argentina)
- Catalina Massa (Universidad de Córdoba, Argentina)
- Rosalba Alzate (Universidad de Antioquia, Medellín, Colombia)
- Carlos Saldarriaga Alzate (Universidad de Antioquia, Medellín, Colombia)
- Milagros Real Pérez (National Center for Quality Control, INS, Peru)
- Fredy Rafael Mostacero Rodríguez (National Center for Quality Control, INS, Peru)
- Antonio Hernández Cardoso (United States Pharmacopeia)
- José M. Parisi (PAHO/WHO)
Last Updated on Tuesday, 13 December 2011 06:32