Line Clearance:–To give the line clearance for the different activity in their concern area like Dispensing, Granulation, Blending, Compression, Capsule, Coating and Packing as per their respective SOPs and batch records.
Monitoring & Verifying of Records: – To monitor day to day activity in all area like Days store, Change part room, Quarantine area and Accessory room. Verifying the logbook, environment monitoring record, inward outward record and inventory records of all concern areas.
In-process Activities: – Perform the in process activities as per the SOPs, BMR and BPR in all concern areas like Compression, Capsule and Packing.
Sampling: – Doing the sampling at different stages like Blending, Compression, Coating, Capsule and Packing as per the SOPs, BMR and sampling plan.
Process Validation activities: – Monitoring of the validation batch at different stages and collection of samples as per the protocol.