Quality Assurance
Shiva Biogenetic never ever compromises on quality. The company always aims to provide high-end quality products for healthier and safer life-styles. The company follows WHO-GMP guidelines & Standard Operating Procedures strictly.
The management themselves assure pre-formulation study, formulation development, protocol submission, stabilities studies, method development and product permissions before manufacturing or developing any molecule to match World-Class Quality Standards. The Company also arranges Bio-equivalence studies and Clinical trials whenever required.
Quality Analysis
QA team intervene with all departments to assure manufacturing of high end quality products
- Implementation & Monitoring of WHO-GMP guidelines, Preparation, Review & Approval of SOP, SMP, STP, Protocol MFR & BPCR
- Product Approvals, Tech Transfers etc from DCGI
- Issuance and Archival of Batch Production & Control Record
- IPQA activities during Production - Regular Inspection at all stages
- Control Sample Management, Product Recall, Handling of Market Complaints, Corrective & Preventive Action (CAPA), On-Going Training, Retention of Records, Product Quality Review, Total Quality Management (TQM) of the Plant, Approval of Deviations & Change Control, Validation & Qualification of Equipment and Process.
