Production:
- To monitor packing and manufacturing activity
Handling and allocation of manpower
Handling of batch packing and activity
Handling of batch manufacturing activity
SAP entries and Online completion of documents, submission and retrieval.
Quality assurance:
- Role of AQA in Routine Laboratory Compliance Monitoring:
On line verification of weight printouts and review of analytical records
Verification of log book entries
Monitoring calibration schedule and Review of calibration reports
Review of working standard analytical reports
Review of volumetric solution reagent preparation records
Archival of analytical reports (RM/PM, IP/FP, Stability, calibration reports and other records)
Role of AQA in Routine Sample Management:
Allotting AR number and issuance of sample & AWR for analysis
Verification of residual samples
Role of AQA in Stability Sample Management:
Charging stability samples
Monitoring stability program and withdrawal of stability samples
Allotting AR number and issuance of sample & AWR for analysis
Review of stability summary reports and trends
Role of AQA in Control Sample Management:
Receipt, storage and maintenance of control sample registers
Annual verification of control samples and reporting of observations
Monitoring of control sample room temperature
Role of AQA in Instrument Qualification:
Approval of qualification of protocols
Review of qualification reports and release of instrument for routine usage
Role of AQA in QMS:
Logging of Lab deviations, OOS, OOT and issuance of QMS documents
Investigation of laboratory Non-compliances
Review of change control and CAPA proposals
Preparation of QMS trends
Self-inspection of laboratory controls
Data integrity audits
Control of master documents (SOPs & Specifications/AWRs)
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