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Manufacturing Ondansetron Injection 2mg/ml (Den Mark Pharmaceuticals Pvt. Ltd.) - A WHO GMP Compliant Process

Ondansetron is a potent antiemetic drug used to prevent nausea and vomiting induced by chemotherapy, radiation therapy, and surgery. Den Mark Pharmaceuticals Pvt. Ltd. is committed to producing high-quality Ondansetron Injection 2mg/ml according to WHO Good Manufacturing Practice (GMP) guidelines with Export-Quality Pharmaceutical products. This comprehensive manufacturing process ensures the final product's safety, efficacy, and consistency.

1. Starting Materials and Pre-Production

  • Material Receipt and Quarantine: All incoming raw materials (Ondansetron API, excipients, and packaging components) undergo strict inspection against predetermined specifications. Non-compliant materials are quarantined and rejected. Approved materials are assigned batch numbers and stored under appropriate conditions.
  • Master Formula Record (MFR) and Batch Production Record (BPR) Review: The production team reviews the MFR, which outlines the formulation, manufacturing process, and quality control parameters. A BPR is prepared, documenting all steps specific to this production batch.

2. Weighing and Dispensing

  • Aseptic Environment: For aseptic manipulations, a designated aseptic area, maintained under positive pressure and strict air filtration, is used.
  • Weighing: Trained personnel, wearing appropriate sterile garments, weigh the precise quantities of Ondansetron API and excipients as per the MFR using calibrated balances.
  • Dispensing: Weighed materials are transferred to pre-sterilized containers within the aseptic area.

3. Dissolving and Mixing

  • Dissolution: Under aseptic conditions, the API and excipients are dissolved in a suitable solvent, following the MFR's order and mixing time instructions.
  • Filtration: The solution is passed through sterile filters to remove particulate matter, ensuring a clear, contaminant-free product.

4. Filling and Sealing

  • Filling Line: The sterilized solution is transferred to a validated filling line. Automated or semi-automated equipment ensures accurate and consistent filling into pre-sterilized vials.
  • Sealing: Vials are hermetically sealed using a validated sealing process to prevent contamination and ensure product integrity.

5. Lyophilization (Optional)

  • Lyophilizer: The filled vials may undergo lyophilization (freeze-drying) in a validated lyophilizer for a longer shelf life. This process removes water content while maintaining product stability.

6. Labeling and Packaging

  • Labeling: Each vial is labeled with pre-printed labels containing product information, batch number, expiry date, and storage instructions. Verification ensures that all labels are accurate and match the BPR.
  • Packaging: Labeled vials and a patient information leaflet are placed in sterile cartons. Secondary packaging (boxes) is applied, ensuring proper labeling and protection during transport and storage.

7. In-process and Finished Product Quality Control

  • Throughout the process, designated samples are withdrawn for in-process quality control testing. This ensures parameters like weight, pH, sterility, and clarity meet the pre-defined specifications.
  • Finished product testing: Per the MFR, a representative sample from each batch undergoes comprehensive testing. This includes chemical analysis, sterility testing, and functionality assays to guarantee the product's quality, safety, and efficacy.

8. Batch Release and Documentation

  • Batch release: Only after all quality control tests meet the established specifications is the batch authorized for release by a qualified person.
  • Documentation: All BPRs, raw material certificates, and quality control test results are compiled and archived for future reference and regulatory audits.

9. Storage and Distribution

  • Finished product storage: Released batches are stored under appropriate temperature and humidity conditions per product specifications.
  • Distribution: The product is distributed through a qualified supply chain, maintaining proper storage and transportation conditions to ensure product quality until it reaches the end user.