The WHO guidelines are used for inspections. Sites in countries with mature regulatory authorities such as the USA, EU, Australia, Japan and Canada are normally exempt from GMP inspections. They do however go through a Desk Review process to verify the validity and scope of approval granted by these mature regulatory authorities. In addition, desk reviews may be conducted instead of actual inspections for plants that would have been inspected by stringent authorities and the WHO PQT. The steps below are followed for a manufacturing site to be inspected under ZAZIBONA;

  • The scheduling of inspections and the coordination of inspectors from different countries is carried out by the SADC MRH Implementing Agency, MCAZ.
  • The team inspecting one site normally comprises of three people: a lead inspector, a co-inspector and an observer, each from a different country. The lead and co-inspector roles are rotated among the participating countries that have competent GMP inspectors.
  • The joint GMP Inspections Coordinator assigns a lead inspector and co-inspector from the countries to which the product has been submitted and in accordance with the inspectors’ rotational calendar.
  • Whilst the joint inspection is conducted by 2-3 inspectors; the final inspection report is prepared in consultation with the rest of the inspectors within ZAZIBONA.
  • A final compliance status is reached collaboratively after consideration of the applicant’s corrective and preventive actions (CAPAs).
  • The responsibility for issuance of a GMP certificate or letter lies with each individual country however, a target of not more than 90 days has been set and agreed amongst the active member states.
  • The final decision is communicated to the assessment coordinator for consideration when the final recommendation is made for the product.