Contract Manufacturers and Contract Laboratories do no longer need to be pre-approved by DMA
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The Danish Medicines Agency (DMA) recently changed its practice to pre-approve contract manufacturers and contract laboratories acceptors.
However DMA mentions a few pre-requisites which need to be considered:
- "The contract giver must ensure that the contract acceptor has a valid regulatory approval (MIA or GMP certificate)."
- "The contract giver must audit its contract acceptors regularly as part of the internal audit programme."
- "There must be a contract between the contract giver and the contract acceptor"
This will be monitored by DMA by random checks and by an updated list of contract acceptors that should always be available at the company. This list must contain defined information about the contract acceptor, the respective audits and the contract itself.
Source: DMA News
Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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