| Personnel | Roles & Responsibilities |
|---|---|
| Quality Control Officer | ✓ To approve or reject starting materials, packaging materials, and intermediate, bulk and finished products in relation to their specifications. ✓ To evaluate batch manufacturing & packaging records. ✓ To ensure that all necessary testing is carried out. ✓ To approve sampling instructions, specifications, test methods and other quality control procedures. ✓ Establishment, implementation and maintenance of the quality system. ✓ Supervision of the regular internal audits or self-inspections. |
| Quality Assurance Officer | ✓ Authorization of written procedures and other documents. ✓ Monitoring & control of the manufacturing and processing environment. ✓ Plant hygiene. ✓ Process validation and calibration of analytical apparatus. ✓ Performance and evaluation of in-process controls. ✓ Retention of records. ✓ Inspection, investigation and taking of samples in order to monitor factors that may affect product quality. |
| Production Officer | ✓ To ensure that products are produced and stored in accordance with the appropriate documentation in order to obtain the required quality. ✓ To approve the instructions relating to production operations, including the in-process controls, and to ensure their strict implementation. ✓ To ensure that the production records are evaluated and signed by a designated person. ✓ To check the maintenance of the department, premises and equipment. ✓ To ensure that the appropriate process validations and calibrations of control equipment are performed and recorded and the reports made available. ✓ To ensure that the required initial and continuing training of production personnel is carried out and adapted according to need. |
| Authorised Personnel | ✓ Compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for sale or supply. |