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Axis 1 / Subject 1 - Knowledge, assessment and local promotion of MEGs

Help for bringing factories up to standard (in Africa, China…)

Audits of local producers in the Democratic Republic of Congo


Jean Christophe PÉLISSIER, pharmacist, AEDES consultant, experience in long term technical assistance in MEG supply systems, management of national purchasing centres, pharmaceutical regulation, purchasing strategies and procedures and medicines quality management.

General scheme of the Presentation
  • Policy principle: FEDECAME has introduced into its purchasing policy a systematic GMP audit of local producers, constituting an important element in the technical qualification of these manufacturers. GMP audits of certain manufacturers in the Democratic Republic of Congo have been carried out on a regular basis since 2003, with support from international experts.
  • Results of GMP audits of local manufacturers carried out for FEDECAME and the lessons learnt from this policy.
Essential questions on which the presentation is based
  • Is the GMP audit of local manufacturers a useful procedure?
  • How should the auditing procedure for local manufacturers be conceived?
  • How can local manufacture be supported?

Help for bringing factories up to standard (in Africa, China...)


Patrick HOET, industrial pharmacist, independent consultant; long experience in industrial medicines production, then substantial experience of audition and production support in countries with low and middle incomes and in emerging economies.

General scheme of the Presentation
  • Presentation of experiences in auditing and supporting medicines manufacturing sides in various African countries (Zenufa experience in Tanzania above all) and in Asia (China in particular).
  • Concept of complexity in pharmaceutical production in the context of low income countries (in Africa amongst others) in relation to the sometimes simplistic messages for promoting local national production (financial and technical aspects).
  • Diversity of situations on the ground: the problems posed are not always similar...
  • The problem of transfers of technology more or less followed up and the more or less clear reasons for such transfers.
  • AQ Platform: the need for consolidation and coordination of audits.
  • Need for an assessment of the production sources of raw materials (this aspect is always neglected but is absolutely essential).
  • Strategic approaches in the sector: pragmatism in application!
  • Same problems with respect to «local bio-equivalence»: financial and technical constraints.
Essential questions on which the presentation is based
  • How to rationalise audits whilst at the same time improving their impact?

OTECI - « Market Intelligence » and experience of technical assistance to manufacturers.


Jacques PILLOY, former raw materials purchaser in a major pharmaceutical company; currently a member of the OTECI network.

General scheme of the Presentation
  • Summary and results of audits and technical assistance carried out in low and middle income countries.
  • OTECI is an organisation consisting of retired volunteers from various industries. The health sector group is composed largely of people who have retired from the pharmaceutical industry.
  • In total 52 visits to producers have been made in 19 countries.
  • OTECI also carries out manufacturing audits (GMP and product assessment) as part of the evaluation of a potential supplier by an international supply agency (MSF, CHMP, etc.) but also provides technical assistance for some manufacturers with the aim of improving quality standards. In this context, OTECI members have carried out pre-audits on behalf of the Pre qualification Programme of the WHO.
Essential questions on which the presentation is based
  • What are the criteria fore success for local production in low and middle income countries?
  • What are the prerequisites for setting up a local production structure?