Prequalification: Training Workshop

Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or
      participating in respective sampling and testing projects

       Nairobi, Kenya,  23 - 25 September 2009 

The working seminar has been organized for Quality Control Laboratories (QCLs) prequalified by WHO, being in process of prequalification and/or participating in WHO organized sampling and testing projects.  The seminar had a three fold objective:

• Introduce participants into risk-based Quality Control (QC) planning, considering available capacities and existing QC networks

• Strengthen sampling and testing projects organized by WHO Prequalification Programme

• Stimulate collaboration among QCLs

The seminar was organized in collaboration with WHO Prequalification Programme, WHO Country Office in Kenya and National Quality Control Laboratory in Kenya.  The European Directorate for the Quality of Medicines (EDQM), the French Agency for Regulation of Health Products (AFSSAPS), the Therapeutic Goods Administration (TGA) from Australia and the Research Institute for Industrial Pharmacy (RIIP) incorporating CENQAM, North-West University in South Africa supported the seminar with the provision of speakers and facilitators.

• Training Programme [pdf]
  

Presentations:

Wednesday, 23 September 2009

• Principles of quality control of registered medicines, non-registered medicines, counterfeits [ppt]

• Quality issues - principal root causes of inferior quality [ppt]

• Specific quality problems with several categories of essential medicines (antibiotics and antituberculosis) [ppt]

• Specific quality problems with several categories of essential medicines (antiretrovirals) [ppt]

• Classification of health risks of medicines for the purpose of sampling and testing projects [ppt]

• Risk-based analysis in pharmaceutical procurement and market analysis [ppt]
  

Thursday, 24 September 2009

• Specific quality problems with several categories of essential medicines (antimalarials)  [ppt]

• Collaboration of assessors, inspectors and QCL staff [ppt]

• Organization of sampling programmes - background information [ppt]

• WHO sampling and testing programmes [ppt]

• Organization of sampling programmes - EU experience [ppt]

• Sampling according to WHO guidelines for sampling of pharmaceutical products and related materials [ppt]

Friday, 25 September 2009

• Interpretation of laboratory findings, what QC cannot say, testing reports [ppt]

• Information exchange and international collaboration in quality testing [ppt]

• Specific tasks and challenges of procuring organizations related to quality control of medicines [ppt]

• GF and GDF quality assurance mechanisms [ppt]

• Quality control of medicines and organization of market surveillance in Kenya [ppt]

• Quality control of medicines and organization of market surveillance in Tanzania [ppt]

• EU article 58 testing - information to national QCL [ppt]

• MJA/MJV Scheme of the OMCL Network [ppt]