1. The WHO Prequalification of Medicines Programme Capacity building agenda
Dr Milan Smid

2. Capacity building - objectives
Good quality submissions for PQ supported by compliance with "good practices"
platform for improvement of drug development, manufacturing, documentation and quality control
Fast regulatory approvals of PQ medicines in recipient countries
technical education of regulators as a platform for strengthening expertise, regulatory efficiency and networking
Reliable quality monitoring
technical education of staff of QCLs to strengthen expertise, effectiveness of quality monitoring and networking
PQP standards and PQP example support strengthening of regulatory systems and capacity of manufacturers in general
Next we will have a short session on Self-inspection.
We then turn to the topic of Personnel. Personnel should be seen by the pharmaceutical manufacturer as its most valuable resource. It is sometimes its most difficult one to manage. Inspectors need to be sure that there are sufficient human resources, with people who have the correct qualifications and acceptable levels of experience. An important issue for you to check is the conflict of interest that can arise if Quality Control is not properly independent of Production. For this reason a full day is required for this subject.
This will be followed by a half-day session on Equipment. If you would like to have any particular piece of equipment discussed please write its name down and hand it to me at the end of this module. If possible we will discuss the item during the Equipment module.
We shall then spend a full day on Premises. Here we are going to be looking at some of the fundamental issues, including the effect of the external environment, on a company’s ability to manufacture products in the appropriate conditions.
This will be followed by a half-day session on Materials. Experience has shown that many problems arise as a result of the selection of unsuitable or impure materials. Many developing countries have financial constraints that work against using materials of the right quality.
QSM TBS/13-17 September 2010

3. Capacity building – team work
1) Trainings of different set-up
2) Technical
assistance &
advice
3) Provision of information,
standards and regulatory
expertise
QSM TBS/13-17 September 2010

4. 1) Trainings Seminars and workshops Training by doing
General: PQ procedures and WHO requirements
Problem oriented, e.g.:
HIV/AIDS, TB, antimalarial or RH products
Pharmaceutical development/paediatric dosage forms, BE/BCS
Manufacture of sterile medicines
Quality of APIs
Trainings of NRA staff and manufacturers frequently combined
Collaboration with third parties frequent involved
Support is given to trainings organized by others
Focus on "training of trainers"
WHO training materials used, when available (GMP, GPCL)
Training by doing
Inspectors, assessors, rotations within PQP
QSM TBS/13-17 September 2010

5. PQP trainings
QSM TBS/13-17 September 2010

6. 2) Technical Assistance
Key objective: Facilitate prequalification of priority medicines
Provision of consultants to advice on
GMP or GCP compliance
Data development and compilation of dossier
Assistance is separated from the assessment / inspections
Assistance may be followed by specific trainings
Assistance is provided free of charge
QSM TBS/13-17 September 2010

7. Technical assistances 2006-2010 (I-VIII)
QSM TBS/13-17 September 2010

8. 3) Provision of information and regulatory expertise
Information related to individual PQ products or manufacturers / CROs
Product list and pending procedures
Public assessment reports (WHOPAR, SPC, PIL)
Public inspection reports (WHOPIR – APIs and FPPs)
Notice of concern / suspension
Development of guidelines and standards
Published training materials / CDs
Technical Briefing Seminars in Geneva
PQ medicines and laboratories, guidelines, training materials
QSM TBS/13-17 September 2010

9. Support to projects relevant for PQP
National authorities indicate the interest to collaborate with WHO and the needs - WHO proposes solutions and supports the actions
WHO focuses on actions having impact on public health aiming to achieve self-sustainability of health and safety management operations in the country
WHO supports projects in countries by co-ordinated effort of Country Offices, Regional Offices and HQ
Key expert resources are frequently external, from the pool of international experts in WHO Member States
Successful projects create benchmark and increase chance for further support and other projects
QSM TBS/13-17 September 2010

10. Contact for communication
Milan Smid, M.D., Ph.D.
Quality Assurance and Safety: Medicines (QSM)
Essential Medicines and Policy (EMP)
QSM TBS/13-17 September 2010