Why does RDC 301/2019 require qualifying the suppliers in person?
All production in the pharmaceutical industries always involves a third-party supplier of IFA (active pharmaceutical input). The point is that even the industry that produces the drug has a high standard of quality on its processes, according to the necessary legislation, it is not uncommon to find IFA suppliers (national or international) that may be outside this same quality standard.
Considering this, ANVISA predicted through RDC 301/2019 (good manufacturing practices premises) the mandatory face to face audits in national and international suppliers of IFAs, since the documentary audit carried out on these suppliers is not effective to ensure the quality of the product.
Although the RDC was published in 2019 (almost 2 years ago), many companies are still in the race to adapt national and international audits of IFAs and other suppliers, not only for costs, but mainly for pandemic complications.
With the possibility of immunization of the population, the procedures of face to face audits become possible again and companies need to program themselves now to ensure the qualification of the supplier in its entirety.
Consider that when an audit is performed, a vendor is not "Qualified" automatically after the audit, but only after the planned action plan and with the actions taken on the critical deviations detected. In addition to the challenge of getting a qualified auditor (or team) for international audits(s), companies also need to worry about who will be responsible for monitoring the actions and who will perform periodic follow - ups with the international supplier to know whether the deviations have actually been made or not.
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