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Brazil makes proposed outsourcing regulations available for comment

By Gareth MacDonald+

09-Dec-2013

ANVISA has set out what it expects of contractors that provide manufacturing, quality control services and drug storage in the Federal Official Gazette of Brazil (DoU) and invited stakeholders to comment.

According to the Brazilian regulator the new document, available here in Portuguese , establishes rules for outsourced drug production conducted by both external organisations - like CROs and CMOs - and in-house units providing such services for pharmaceutical companies.

In addition to definition basic parameters like quality and process control, ANVISA also assigns responsibility for ensuring that outsourced production and analysis is carried out to appropriate quality standards, with the onus falling on both sponsor and contractor.

The regulator also sets out what should be included in contracts covering any outsourced production and analysis work, ranging from which party is responsible for product release and what contractor must do in the event of deviations.

“Article 17 The responsibility for product release is independent of the registration holder in any stage of production, quality control, or storage have been made ​​by third parties , being co -responsible for that task to the contractor under the contract .

“Article 18 The contract should clearly state the person appointed as the Quality Assurance contractor company, while releasing each batch of product for sale or issue the certificate of analysis , exercises his full responsibility and ensures that each batch has been manufactured and checked accordance with the requirements of registration .”

ANVISA also reiterates that: “In all cases the contractor is jointly accountable to health authorities, along with the sponsor, for the technical, operational and legal aspects inherent to the activity object of outsourcing.”

The contractor shall ensure that the sponsor is informed of any problem related to the product, services or tests which could jeopardize the quality of the product as well as the contractor's facilities , equipment , personnel, other materials or other products.”

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