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Anvisa extends comment deadline on excipient GMP after strikes

By Gareth Macdonald , 23-Aug-2012
Last updated on 23-Aug-2012 at 14:50 GMT

Brazilian regulator Anvisa has extended the deadline for public comment on plans to require excipient manufacturers to be GMP compliant after a month of industrial action by government workers.

The National Health Surveillance Agency (Anvisa) first issued its plan for public consultation in May – Portuguese version available here – and asked interested parties to share their thoughts by August 4. 

However, in a statement published late yesterday the agency said it has extended the consultation period for another 60 days.

According the online feedback from so far Anvisa has received just 54 comments with 18 respondents agreeing with the proposals, 10 partially backing the plan and one suggesting regulation is unnecessary. 

The decision to extended the deadline comes after more than a month of industrial action by government workers, including Anvisa staff, that has caused disruption to drug and medical device imports.

The agency issued an action plan to make sure its regulatory operations could continue during the strike, which was ongoing at the time of publication .

Scope of the regulations

Under the proposed quality rules excipient manufacturers supplying the Brazilian market would need to be licensed and inspected by Anvisa and say at which stage in the manufacturing process GMP steps are applied.

Beyond this manufacturers would need to detailed in-house quality management measures, provide details of staff good manufacturing practices (GMP) training, ensure that facilities are not used to produce active pharmaceutical ingredients (APIs) and excipients and that full documentation of all components is maintained.

Also under the proposed guidelines old facilities would be given 12 months to bring the manufacturing operations up to code, but new plants would be required to comply with the regulations from the outset.

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