Depend on national legislation. Examples:
For new plants
- No manufacturing licence/GMP certificate until compliance
For licence/certificate holders
- Suspension/withdrawal of marketing authorization for product(s)
- Suspension/withdrawal of manufacturing licence/GMP certificate
- Access to appeal
Countries use different strategies to ensure that legislation is enforced. The regulatory measures available to the authority in cases of non-compliance are described in the national legislation. If compliance with GMP guidelines is a legal requirement, the inspectors must know which sanctions they can impose on manufacturers who do not comply.
For new manufacturing plants the issuance of a licence can be delayed. If a company is required to have a licence in order to distribute products made in the plant, this is usually sufficient to improve compliance.
For licences already issued, it may be sufficient to warn that the authority may withdraw the licence.
The authority may be empowered to impose fines. This measure may be used if non-compliance does not constitute a serious health risk.
In some countries the authority has the legal power to suspend or withdraw the marketing authorization for a product if the manufacturer does not comply with GMP during production of that specific product. The authority could also suspend the issue of a certificate of compliance with GMP.
Suspending or withdrawing the manufacturing licence and closing down a plant are strong measures that should be used when products from the plant is considered to constitute a serious hazard to health. In severe cases of non-compliance the authority may consider initiating court proceedings. The authority may need to spend substantial time and resources if they decide to do this, which should not be undertaken without careful consideration.
The manufacturer should have access to appeal to a higher authority about all regulatory decisions, including sanctions for non-compliance with GMP.