Den Mark Pharmaceuticals Pvt. Ltd. is committed to producing high-quality pharmaceutical products adhering to WHO-GMP guidelines and is a GMP-certified pharmaceutical exporter. This document outlines the manufacturing process for Omeprazole Injection 40mg, a proton pump inhibitor used to treat gastrointestinal disorders..
1. Starting Materials and Documentation:
- Obtain high-quality Omeprazole API (Active Pharmaceutical Ingredient) and excipients (inactive ingredients) from qualified suppliers with valid Certificates of Analysis (CoA).
- Maintain a documented receiving procedure, ensuring proper identification, quarantine, and sampling for testing against specifications.
2. Pre-Production:
- Review production orders, ensuring all materials, equipment, and personnel are available.
- Prepare a detailed Batch Production Record (BPR) documenting every step.
- Calibrate and qualify all equipment involved in the production process.
3. Weighing and Dispensing:
- Aseptically weigh the required quantities of Omeprazole API and excipients under a Laminar Airflow (LAF) hood.
- Double-check the weights by a qualified person.
4. Mixing and Dissolving:
- Transfer the weighed materials to a sterilized mixing vessel.
- Use purified water for injection (WFI) to prepare the solution, following validated mixing procedures.
- Ensure complete dissolution and uniformity of the solution.
5. Filtration:
- Pass the solution through pre-sterilized filters with a pore size appropriate to remove any particulate matter.
- Verify filter integrity after use.
6. Filling and Sealing:
- Transfer the sterile solution to pre-sterilized vials (40 mg/vial).
- Utilize a validated aseptic filling line to minimize contamination risks.
- Ensure proper vial closure with sterilized stoppers and seals.
7. Lyophilization (Freeze Drying):
- Load the filled Omeprazole Injection 40 mg vials into a lyophilizer and follow a validated freeze-drying cycle.
- This process removes water content while maintaining product stability
8. Sterilization:>
- Depending on the chosen container-closure system, employ a validated sterilization method, such as aseptic filtration or terminal sterilization.
- Document the sterilization cycle parameters and monitor them throughout the process.
9. In-Process Quality Control:
- Conduct sampling and testing at designated checkpoints throughout the process.
- Analyze Omeprazole Injection 40 mg samples for pH, sterility, and active ingredient concentration according to pre-defined specifications.
- Reject batches that fail to meet quality standards.
10. Labeling and Packaging:>
- Apply pre-printed labels on finished Omeprazole Injection 40 mg vials containing product information, batch number, expiry date, and manufacturer details.
- Package the labeled Omeprazole Injection 40 mg vials in sterilized cartons following GMP guidelines.
11. Quarantine and Release:
- Quarantine the finished Omeprazole Injection 40 mg batch until all quality control tests are complete and approved.
- Release the batch only after a qualified person reviews the BPR and verifies compliance with specifications.
12. Documentation and Records Management:
- Maintain comprehensive documentation for all production activities, including BPRs, raw material certificates, equipment calibration records, and quality control data.
- Archive all documents as per regulatory requirements.
Additional Considerations:
- Employ a trained and qualified workforce adhering to GMP regulations.
- Maintain a clean and hygienic production environment.
- Implement a robust Quality Management System for continuous process improvement.
- Conduct regular audits to ensure GMP compliance.
By following these steps and adhering to WHO GMP guidelines, Den Mark Pharmaceuticals Pvt. Ltd. can ensure the consistent production of high-quality, safe, and productive Omeprazole Injection 40 mg.