Introduction:
Den Mark Pharmaceuticals Pvt. Ltd. is one of the top pharmaceutical manufacturers committed to producing top-quality pharmaceutical products adhering to the stringent guidelines set forth by the World Health Organization's Good Manufacturing Practices (GMP). This document outlines the manufacturing process for Tranexamic Acid Injection 100mg/ml, ensuring efficacy, safety, and consistency.
1. Raw Material Procurement and Testing: Den Mark Pharmaceuticals procures high-quality raw materials from approved suppliers. Each batch undergoes rigorous testing for purity, identity, and potency. Tranexamic Acid, the active ingredient, is sourced from reputable manufacturers with proper documentation and certificates of analysis.
2. Formulation: The formulation process begins with accurately weighing and mixing Tranexamic Acid with sterile water for injection. The solution is carefully pH adjusted to ensure stability and compatibility with the human body.
3. Sterilization: The prepared formulation undergoes sterilization using validated processes such as filtration or autoclaving to eliminate any microbial contamination while maintaining the integrity of the product.
4. Filling and Packaging: To prevent contamination, the sterile solution is filled into vials under controlled conditions. The vials are then sealed using high-quality rubber stoppers and aluminum caps to maintain sterility. Proper labeling with all necessary information, including dosage, batch number, and expiry date, is done according to regulatory requirements.
5. Quality Control: Rigorous quality control measures are implemented throughout the manufacturing process. Samples are collected at various stages for analysis, including chemical assays, sterility testing, and stability studies. Any specification deviation prompts immediate corrective action to ensure product quality and safety.
6. Stability Testing: Stability testing is conducted on representative samples to assess the product's shelf life under various storage conditions. This ensures that the Tranexamic Acid Injection maintains its potency and efficacy throughout its intended shelf life.
7. Packaging and Distribution: Once the Tranexamic Acid Injection 100mg/ml passes all quality control tests and stability assessments, it is packaged into final containers, typically cartons containing multiple vials, and prepared for distribution. Care is taken to ensure proper handling and storage conditions to prevent product degradation during transportation.
8. Regulatory Compliance: Den Mark Pharmaceuticals adheres strictly to regulatory requirements set forth by WHO GMP guidelines and other relevant authorities. All manufacturing processes are documented, and records are maintained for traceability and accountability.
Conclusion: The Tranexamic Acid Injection 100mg/ml manufacturing process at Den Mark Pharmaceuticals Pvt. Ltd. exemplifies a commitment to quality, safety, and compliance with WHO GMP guidelines. From raw material procurement to final packaging and distribution, every step is meticulously executed to produce a pharmaceutical product that meets the highest standards of efficacy and reliability.