Ensuring the shopfloor compliance and Inprocess quality assurance activities
1) Authorizing the Line Clearance during the product change over in warehouse and production (manufacturing and packing ).
2) Conducting quality examination in regular intervals by performing in-process checks during the production process.
3) Sampling of intermediates finished drug products, Reserve samples & stability samples from manufacturing and Packing stages and submission to Quality Control unit for testing.
4) Involvement in hold time study program by performing the sampling and retaining the required sample in controlled storage. Submission of sample to quality control lab on regular intervals as per sampling plan.
5) Ensuring the compliance and performing calibration of IPQC-Instrument.
6) Acknowledgement of Maintenance request and performing the impact assessment before closure.
7) Performing visual inspection, destruction of reserve sample and Maintenance of reserve sample room.
8) To review batch records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
