HIGH POTENCY APIS
There are also legal requirements surrounding the actual transport and security arrangements . These need to made dependent upon the :
• Specific schedule of the controlled substance in the local market
• Size of the shipment
• Point of origin and destination
• Organisations involved in the movement of the controlled substance The substance remains the responsibility of the supplier until the recipient acknowledges receipt . The transport also needs to be handled by licensed companies and it is the legal owner who carries this responsibility . It is good practice to develop standard operating procedures to ensure robust systems are in place covering the transportation requirements of controlled substances .
Safe manufacturing
When it comes to the use of controlled substances in the drug production process , drug companies need to ensure that there is no accidental effect on worker health and safety . This is particularly necessary in the case of hallucinogens , which can pose safety risks for any workers if they are exposed . It is vital to maximise containment on the production line , using cleanroom techniques , closed production lines , air circulation measures and high-performance personal protective equipment . The ‘ street value ’ of regulated substances is very high . Therefore , it is also important to install tracking equipment and keep precise inventories of stocks and intermediate products of controlled substance . This is not just a question of minimising waste and cost ; those are key security measures to make sure that no amount of regulated material is removed from the site without approval . Failing to take these measures can lead to prosecution , revocation or curtailment of the authorisations and licences . As such , it is crucial to maintain the highest standards of compliance and work with partners with a similar commitment to minimising the risk of potential failures in compliance .
Need for support
The complexity of the global regulatory environment for controlled substances , combined with the rigorous containment requirements for production lines , means that not every pharmaceutical company has the capacity or capability to handle controlled substances on their own . If they want to benefit from the potential of controlled substances to achieve innovative and more effective drug products , they need to work closely with expert CDMO partners that have experience of handling these materials safely . Such partners can provide a wide range of specialist support . These include the development of the actual manufacturing processes for products containing controlled substances , to advising on regulatory requirements , to the development of security ‣
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