Unlike any other drug and drug product suppliers/traders , CRMO provides many value added services once the manufacture is qualified , Technology is transferred where applicable , product(s) approved after validation batches and scale up completed. CRMO visits manufacturing site at regular intervals and keeps vigilant watch on behalf of client companies .
CRMO ensures that
The Manufacturing process is followed with out any deviation
cGMP is not compromised at any point in time .
Product release is as per approved specifications and using validated MoA
product quality form all batches is thoroughly checked before each consignment is shipped
any grievances or complaints from the Buyers are promptly attended and proper investigations are carried out.
Production planning and Raw material inventory planning at the manufacturing site is constantly monitored to ensure timely deliveries.
Any technical assistance needed for improving process efficiency , yield improvement, throughput enhancement, energy cost saving , etc is provided and changes are made effective only through Change control procedures.
Periodic review of documentation is carried
During regulatory and customer audits necessary support is provided.