Preparation , Revision & distribution of SOP’s , Specifications ,STP, Protocol, COA.
Preparation, Issuance and review of MFR, BMR and BPR, Qualification protocol and Reports ,Stability Study protocol & reports ,Process Validation protocol and report, Method Validation protocol and report ,Cleaning Validation protocol and report.
Preparation & Review of APQR
Vendor evaluation and qualification for raw materials, Packing Materials.
Artwork Approval for Packing Material.
Conduct Training as per training Scheduled.
(IPQA) In process check during, Dispensing, granulation, compression, capsule filling and coating stage, blister stage and review of in process result with standard section.
Sampling of Raw material, Intermediates & finished product.
Maintain the reserve sample of finished product & its Records.
Preparation Stability schedule, protocol and summery sheet.
Handling Digno Sure software for stability study.
To prepare Site Master File, Validation Master Plan.
Logging and handling the change control, deviation. self inspection
Maintain Market complaints Records.
Daily Calibration of Electronic Balance.
Calibration Of instruments as applicable & as required.
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