All products are processed in accordance with Master Formula Record. The activities are documented in the Batch Manufacturing Record and the Batch Packing Record. On line documentation are carried out.
All the API, Excepients, Primary packing materials, Filters & Tubing’s required to manufacture the product are procured from Approved Vendors. All the manufacturing activities are carried in house and all the relevant documents related to process are enclosed with the BMR for authenticity. The equipments used for the process are all well qualified and calibrated at pre defined intervals.
The processing of the product is carried in Class C, where as the filtration & filling of the product is carried in Class A/B. The washing and sterilization of the primary packing components are carried in Class D areas. Sterilization of these primary packing components are done by Autoclave/Sterilizing Tunnel.
All critical activities are carried under LAF’s. During Filtration, Pre & Post bubble point tests are performed to check the integrity of the filters. As per the need of the product, pre and post gassing of Nitrogen is performed on the products during filling. Continuous Particle Monitoring is performed during filling.
Products which are terminally sterilized are also processed as aseptic product with same procedure as an aseptic product is processed.100% visual inspection is performed on the filled units using automatic visual inspection machine. The rejects are classified and documented. Visually inspected vials are further processed to pack using automated labeling & cartoning machines.
The finished products are transferred to bonded ware house for further release for distribution by QA. Media Fills are performed at predefined intervals to assess the filling line qualification. Recovery Studies (Sweep Time Study) are performed to establish the time taken to retain the normalcy of the class after turbulence.