Manufacturing Process of Artemether Injection 75mg/ml by Den Mark Pharmaceuticals Pvt. Ltd.
Den Mark Pharmaceuticals Pvt. Ltd., a bulk drug manufacturing company, ensures everything is planned and prepared carefully following WHO Good Manufacturing Practice (GMP) criteria before starting production. This entails obtaining quality raw materials, verifying and calibrating machinery, and educating staff on correct production procedures.
1. Starting Materials and Documentation:
- Procure artemether raw material from qualified suppliers with valid Certificates of Analysis (CoA).
- Ensure all materials, including solvents, filters, and excipients, meet pharmacopoeial grades.
- Maintain a documented receiving procedure for materials, verifying quantity, integrity, and CoA against pre-approved specifications.
2. Pre-Production:
- Preparation: A designated production team reviews the batch production record, ensuring adherence to the master formula and manufacturing instructions.
- Weighing: A calibrated weighing balance accurately weighs the artemether and excipients according to the batch size.
- Quarantine: Weighed materials are labeled and quarantined in designated storage areas until release for production.
3. Manufacturing:
- Dissolution: Artemether is dissolved in a suitable solvent, following aseptic techniques within a Class 100 cleanroom environment.
- Filtration: The solution is passed through sterile filters of appropriate pore size to remove particulate matter.
- Volume Adjustment: A sterile diluent is added to achieve the final volume of the injection solution.
- Mixing: The solution is thoroughly mixed using a validated method to ensure homogeneity.
4. Quality Control:
- Sampling: Aseptic samples are taken at designated stages (dissolution, filtration, final solution) for in-process quality control testing.
- Testing: Samples of Artemether Injection 75mg/ml are analysed for parameters like Artemether concentration, sterility, pH, and appearance, following pre-defined specifications.
- Release Criteria: The batch is released for filling only if all tests meet the established acceptance criteria.
5. Filling and Labeling:
- Filling Line: The sterile solution is filled into pre-sterilized vials using a validated aseptic filling line within the cleanroom.
- Labeling: The Artemether Injection 75mg/ml vials contain the product name, concentration, batch number, expiry date, manufacturer details, and storage conditions.
6. Packaging and Quarantine:
- Inspection: Filled and labeled Artemether Injection 75mg/ml vials are visually inspected for defects and compliance with labeling specifications.
- Leakage Testing: Vials undergo a leak detection test to ensure container integrity.
- Quarantine: The finished Artemether Injection 75mg/ml batch is quarantined until final release approval.
7. Final Release and Documentation:
- Review: The Quality Assurance department reviews all production and quality control documents.
- Batch Release: The batch is distributed upon successful review and adherence to GMP guidelines.
- Batch Records: Complete and accurate batch records are maintained for future reference and traceability.
8. Additional Considerations:
- Cleaning and Sanitation: To prevent contamination, implement a validated cleaning and sanitation program for all equipment and production areas.
- Environmental Monitoring: Regularly monitor the cleanroom environment for temperature, humidity, and microbial levels.
- Waste Management: Implement a system for safe disposal of waste generated during production, following environmental regulations.
- Staff Training: Personnel involved in manufacturing are trained on GMP principles, aseptic techniques, and relevant procedures.
Following this outlined process and adhering to WHO GMP guidelines, Den Mark Pharmaceuticals Pvt. Ltd. can ensure consistent production of high-quality Artemether Injection 75mg/ml.