Line clearance of area and Equipments as per checklists of SOP/ batch records at various stages of dispensing, manufacturing and packing activity of all dosage forms.
1.2
Raw Material and Packing Material Verification as per Dispensing Slip after Line Clearance.
2.0
In Process activity.
2.1
Approval of Specimens (i.e. Label, Carton, Insert, etc.)
2.2
In Process control as per mentioned in SOP and batch records at various stages of all dosage forms (i.e. Compression, Coating, Filling, Sealing, Drying, Washing, Carton coding, Labeling, Packing etc.).
2.3
Verification of various steps of Manufacturing and Filtration Stage.
2.4
Reconciliation and Yield Calculation verification.
2.5
Finished Goods transfer verification.
2.6
Material Return Note verification.
2.7
Pre dispatch Goods Verification before dispatch of Finished Goods.
2.8
Data Logger handling for Finished Goods Transportation.
2.9
Verification of various steps for Online Track and Trace System.
2.10
Cleaning Verification of Sampling Rod and Holding Vessels and maintain the logs.
3.0
Monitoring of cGMP practices at shop floor.
4.0
Sampling Activity.
4.1
Sampling of in process bulk product after completion of Bulk Manufacturing.
4.2
Sampling of Finished Product after completion of respective activities i.e. compression, coating, filling etc.
4.3
Collection of Wash water samples after cleaning of equipment(s).
4.4
Collection of Process Validation, Hold Time and Cleaning Validation Samples as per protocol.
4.5
Collection of Retain Samples as per SOP and Stability Samples as per Request.
4.6
Collection of Registration Samples as per RA request.
5.0
Verification of status labels on equipments and containers.
6.0
Verification and Review of Documents.
6.1
Review of temperature, relative humidity and differential pressure records,
6.2
Operational and Cleaning records and related documents.
6.2
Review of batch manufacturing and batch packing records during batch processing and after completion of batch processing.
6.3
Review of Logbooks.
7.0
Disposition Verification of Raw material, Packing material, in process/ semi-finished and finished products.
8.0
Raw Material, Primary Packing Material and Secondary Packing Material dispensing activity verification.
9.0
Handling of QMS related activities.
9.1
Initiation of Deviation.
10.0
Annual Product Quality Review.
10.1
Collection of Data for APQR.
11.0
Handling of Documents.
11.1
Numbering and Evaluation of Breakdown Memo and Predictive Maintenance format.
11.2
Numbering of Raw Material, Packing Material, Semi-finished and Finished Product Disposition format.
11.3
Numbering of Online Material Rejection Format.
11.4
Requisition for issuance of Logbooks and Annexes as per requirement.
📌 Officer QA IPQA-Thol
🏢 Troikaa Group
📍 Thol
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