The World Health Organization’s technical reporting series guidelines are used as standards / reference guidelines for ZaZiBoNa inspections. However other guidelines like PIC(s) can be referred to. The collaborative initiative has also developed guidelines which can be located under the Guidelines section of the website.
Read MoreRoutine inspection frequency is determined using a risk-based approach. The approach considers the nature of the dosage forms, complexity of the manufacturing process, previous inspection history and the number and nature of the noted shortcomings among other issues. The inspection frequency is therefore determined at the end of the previous inspection and may vary from
Read MoreZaZiBoNa conducts routine inspections for sites that receive approval of their products through the collaborative process, for sites that were previously inspected under the initiative.
Read MoreThe period of validity of a ZaZiBoNa inspection ranges from 1 to 3 years depending on the assigned risk. A risk-based approach which considers the nature of the dosage forms, complexity of the manufacturing process, previous inspection history and the number and nature of the noted shortcomings among other issues is used to determine the
Read MoreGMP recognition and certification of a manufacturing facility after a ZaZiBoNa inspection is at a country level. After the inspection, each country is responsible for issuing GMP approval or certification in line with the recommended outcome and in line with national processes.
Read MoreFacilities inspected by SRAs are subjected to desk reviews and this encompasses the review of the inspection report and compliance report, among other documents that should be submitted.
Read MoreCurrently ZaZiBoNa only considers desk reviews for sites that would have been inspected by Stringent Regulatory Authorities. This position is anticipated to be in force until such a time when the ZaZiBoNa initiative reaches mutual recognition
Read MoreIt should be noted that the ZaZiBoNa initiative is still at work sharing and capacity building stage, therefore inspections conducted by individual member states are not yet being considered for approval of products being considered jointly under the initiative. The facility will therefore be subjected to a ZaZiBoNa inspection, where two or three member states
Read MoreCurrently no, only joint inspections done under the ZaZiBoNa initiative can be recognized. However, the individual national agencies may consider the scope and outcome of these other inspections.
Read MoreJoint inspections reduce the number of inspections performed at a facility resulting in potential saving in time and resources ordinarily incurred when a facility is subjected to multiple inspections by different regulatory Authorities. The outcomes of the inspections are generally accepted by all SADC Member States though each retains the right on the final approval
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