Building Quality In Upstream

DSC_6401_edited.jpg

Quality Assurance

  • Initiation, approval and distribution of procedures (SOP’s)

  • Coordination and approval of validations & qualifications

  • Handling of Incidents, Deviations, Change controls

  • Training

  • CAPA

  • Storage and monitoring Finished Product Retention / Control samples.

  • Handling and Investigation of market Complaints.

  • Product Recall.

  • Batch Release of Finished Goods (SAP)

  • Self Inspection.

  • Vendor Qualification

  • Product Quality Review

  • QC Lab is independent from the Production Area.

  • Responsible for Sampling, testing and releasing of Raw materials and packing materials.

  • Reporting and Investigation of Out of specification & Out of Trend (if any).

  • Primary, working and Reference standards procurement, standardisation and storage.

  • Storage and monitoring Raw Material Retention / Control samples.

  • Microbiological sampling, testing and releasing.

  • Sampling, Testing and Releasing of RM, PM, In-process, Finished product & Stability samples.

  • PPE’s are in place for personnel safety.  

Quality Control