ZAZIBONA

ZAZIBONA GMP inspections are conducted to support product registration. Once a product has been accepted for review under ZAZIBONA, the manufacturing will be inspected jointly by inspectors (2 – 3) selected from the countries to which the application was submitted, for compliance with cGMP standards. Presently, inspections conducted by individual member The inspections are conducted in line with the WHO GMP Technical report series. Reliance is applied on GMP inspections by SRAs and facilities with a valid GMP certificate from an SRA are subjected to desk reviews. A desk review involves the review of the inspection report and compliance report, among other documents that should be submitted. The GMP inspection closure procedure for a manufacturing facility after a ZAZIBONA inspection is conducted at a country level i.e, each country is responsible for issuing a closure letter or a GMP certificate.