Quality Control Procedure
Purpose
The purpose of this SOP is to establish guidelines for conducting quality control checks on incoming and outgoing products in the pharmaceutical warehouse to ensure compliance with quality standards and regulatory requirements.
Scope
This SOP applies to all personnel involved in quality control activities within the warehouse.
Responsibilities
- Warehouse Manager: Overall responsibility for implementing quality control procedures and ensuring compliance.
- Quality Control Supervisor: Responsible for overseeing quality control activities and coordinating with relevant departments.
- Quality Control Inspectors: Responsible for conducting quality checks on incoming and outgoing products.
- Operations Team: Responsible for implementing corrective actions based on quality control findings.
Procedure
- Incoming Product Inspection:
- Receive incoming products and verify the accuracy of quantities against purchase orders.
- Inspect incoming products for damage, defects, or deviations from specifications.
- Check product documentation, including certificates of analysis and manufacturing records.
- Outgoing Product Inspection:
- Review outgoing products and verify the accuracy of quantities against sales orders.
- Inspect outgoing products for packaging integrity, labeling accuracy, and overall quality.
- Ensure that all required documentation, including batch records and certificates of compliance, is included with the shipment.
- Quality Control Checks:
- Conduct visual inspections and functional tests on products according to established quality control procedures.
- Use calibrated measuring instruments and equipment to perform dimensional or analytical tests as required.
- Record inspection results and document any deviations from quality standards or specifications.
- Corrective Actions:
- Implement corrective actions for non-conforming products, including quarantine, rework, or rejection.
- Notify relevant departments and stakeholders of quality control findings and corrective actions taken.
- Review and update quality control procedures as needed based on feedback and continuous improvement efforts.
Abbreviations
- SOP: Standard Operating Procedure
Documents
- Quality Control Checklist
- Non-Conformance Reports
- Corrective Action Requests
- Quality Control Procedure Manual
SOP Version
Version 1.0