Quality

Quality Management System

At Shivamani Pharma Pack, quality is not just a process — it is a promise. We believe in “delivered quality”, ensuring that every shipment is released with a Certificate of Analysis (COA) and a unique batch reference number, following rigorous final testing at the time of dispatch.

• Certifications & Compliance: We are proud to be accredited with ISO 9001:2015 Quality Management System certification. Our Drug Master File (DMF) Type-III registration with the USFDA further validates our commitment to sourcing raw materials exclusively from globally reputed suppliers, meeting USP Type-I glass standards.
• Incoming Material Inspection: Every batch of raw material undergoes a thorough incoming inspection based on clearly defined acceptance criteria, ensuring only the highest quality inputs enter our production process.
• In-Process Quality Control: Our quality control team conducts continuous inspections during production to identify any deviations at the earliest stage and implement immediate corrective measures. This in-process monitoring ensures that compliance to specifications is consistently maintained throughout the entire production cycle.
• Packing Stage Inspection: A random inspection at the packing stage provides an additional layer of assurance, confirming that every product dispatched meets the customer’s exact specifications.
• Traceability & CAPA System: Shivamani maintains a well-defined traceability system that tracks every product from raw material to finished goods. This robust system supports effective Corrective and Preventive Action (CAPA) in the event of any discrepancy, minimizing the risk of recurrence and ensuring continuous improvement.
• Documented Quality System: Our thoroughly documented quality management system ensures that quality standards are routinely met, potential errors are minimized, and every process is consistently aligned with regulatory requirements.
• Pharmacopoeia Compliance: All tubular glass containers manufactured by Shivamani comply with the requirements of leading international pharmacopoeias, including:
  • United States Pharmacopoeia (USP)
  • European Pharmacopoeia (EP)
  • Indian Pharmacopoeia (IP)
  • International Standards (ISO)