On October 19th 2017, ANVISA published RDC nº 183 which complements the provisions of RDC nº 39/2013. The new legislation amends the list of documents required for GMP application protocol, making it mandatory to submit further information on the latest inspections and audits carried out at the manufacturing plant subject to certification. This RDC also brings the GMP concession as a priority when it happens through specific inspection programs, which will be defined based on a health risk assessment that considers the intrinsic risk of the devices, the complexity of the manufacturing processes, the technologies involved, the historical data of inspection, monitoring and registration of the products.
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We appoint as highlights of this new Resolution, the situations under which the GMP concession may occur from now on:
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I – upon presentation of a valid audit report, issued by a third auditor, according to specific programs, both recognized by ANVISA;
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II – from the use of confidential information on inspections, received under Agreements or Agreements with sanitary authorities of other countries;
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III – upon assessment of an inspection report or audit that is issued by the health authority of a member country of the IMDRF or by a third party accredited by it;
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IV – upon evaluation of an audit report that is issued by a third auditor that has been recognized by ANVISA;
V – by conducting a risk analysis for the evaluation of the need to perform on-site inspection prior to the granting of the GMP Certificate, in the case of petitions that do not fit or do not meet the requirements established for the previous sections.
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The new resolution opens precedents for the concession of international GMP certificate without the inspection of ANVISA. Companies that have not yet had the international inspection scheduled or performed by ANVISA must pay attention to the presentation of the additional documents (described in article 4 of the Resolution) and a formal statement regarding the maintenance of interest in GMP certificate concession, within the up to 60 days.
DOMO Salute is attentive to the changes in GMP certification procedures resulting from the publication of the new Resolution.
Questions or information: domosalute@domosalute.com.br or +55 (51) 3377-4658.