Manufacturing Sodium Valproate Injection 100mg/ml at Den Mark Pharmaceuticals Pvt. Ltd. - A WHO GMP Compliant Process.
Top-quality Sodium Valproate Injection 100mg/ml is a medication primarily used to treat seizures, bipolar disorder, and migraine headaches.
Den Mark Pharmaceuticals Pvt. Ltd., a Reliable Medicine Supplier, follows WHO GMP (Good Manufacturing Practice) guidelines to ensure the consistent production of high-quality Sodium Valproate Injection 100mg/ml. This process prioritizes quality control and minimizes contamination risks at every step.
1. Raw Material Acceptance and Storage:
- All incoming raw materials, including Sodium Valproate API (Active Pharmaceutical Ingredient), excipients (inactive ingredients), and sterile water for injection, undergo rigorous testing against predetermined specifications.
- Qualified materials are assigned a unique batch number and stored in the quarantine area under designated conditions.
2. Weighing and Dispensing:
- A designated weighing area, with calibrated balances, ensures accurate dispensing of Sodium Valproate API and excipients according to the pre-approved formulation.
- Each component is weighed and documented by a qualified technician.
3. Dissolving and Filtration:
- In a designated cleanroom environment, the API and excipients are dissolved in sterile water for injection within a sanitized mixing vessel.
- The solution is filtered through a sterile membrane filter to remove particulate matter.
4. Filling and Sealing:
- The sterile solution is transferred to a filling line within the aseptic processing area. The filling line is equipped with automated equipment to minimize human intervention and contamination risks.
- Vials are pre-sterilized and dehydrogenated to ensure sterility. The solution is filled into vials under aseptic conditions, followed by immediate stoppering and sealing.
5. Lyophilization (Freeze-Drying):
- Filled vials are transferred to a lyophilizer, where the solution is frozen at a controlled temperature.
- Under a high vacuum, the frozen water is sublimated (converted directly from solid to gas) without melting, resulting in a sterile cake of Sodium Valproate within the vial.
- This process preserves the stability and potency of the medication.
6. Labeling and Inspection:
- Upon completion of lyophilization, vials are transferred to a designated labeling area.
- Pre-printed labels containing product information, batch number, expiry date, and manufacturer details are affixed to each vial using tamper-evident labeling.
- Each vial undergoes a thorough visual inspection for defects like cracks, leaks, or particulate matter.
7. Sterilization:
- Sealed and labeled Sodium Valproate Injection 100mg/ml vials are then subjected to a validated sterilization process, typically using a steam sterilization autoclave.
- The sterilization cycle parameters (time, temperature, pressure) are precisely controlled and documented.
8. In-Process and Final Product Testing:
- Throughout manufacturing, samples of Sodium Valproate Injection 100mg/ml are collected at designated checkpoints for in-process quality control testing.
- Parameters like sterility, pH, clarity, and potency are rigorously evaluated against pre-defined specifications.
- After sterilization, a final batch sample undergoes comprehensive testing per the pre-approved protocol. This ensures the finished product meets all quality and safety standards
9. Packaging and Quarantine:
- Approved finished Sodium Valproate Injection 100mg/ml batches are packaged in sterile containers with product leaflets containing essential information for healthcare professionals.
- Packaged batches are placed under quarantine until final release approval is granted.
10. Batch Release and Distribution:
- Upon completing all testing and documentation, a qualified person reviews the entire batch history and authorizes its release.
- Released batches are stored under designated warehousing conditions before distribution to healthcare providers.