Den Mark pharmaceuticals Pvt. Ltd. is focused on manufacturing Quality Pharmaceutical Products while following the strict requirements established by the Good Manufacturing Practices (GMP) of the World Health Organization. This comprehensive manufacturing process outlines the steps in producing 40 mg of Pantoprazole Injection, a vital medication for gastrointestinal disorders.
Step 1: Raw Material Procurement and Testing
The manufacturing process begins with procuring high-quality raw materials from approved suppliers. Each raw material undergoes rigorous testing in our state-of-the-art laboratory to ensure compliance with WHO GMP standards. Pantoprazole sodium, the active pharmaceutical ingredient, is tested for purity, potency, and identity before being accepted for production.
Step 2: Formulation
The formulation process begins once the raw materials pass the stringent quality control tests. Pantoprazole sodium is carefully weighed and mixed with excipients such as sterile water for injection, sodium hydroxide, and sodium chloride to achieve the desired concentration and pH level. The formulation is prepared under controlled conditions to maintain uniformity and consistency.
Step 3: Sterilization
Sterilization is a critical step in ensuring the safety and efficacy of the final product. The formulated solution is sterilized using validated techniques such as filtration or heat sterilization. This process eliminates microbial contamination while preserving the integrity of the active ingredient.
Step 4: Filling and Packaging
The sterile Pantoprazole Injection solution is filled into vials under aseptic conditions using automated filling equipment. Each vial is accurately filled with the specified dose of Pantoprazole Injection 40 mg. After filling, the vials are sealed with sterile closures to maintain product sterility.
Step 5: Labeling and Packaging
Once filled and sealed, the vials undergo labeling with all necessary product information, including dosage strength, expiration date, lot number, and storage instructions. The labeling process is automated to ensure accuracy and compliance with regulatory requirements. After labeling, the vials are packaged into cartons or trays for distribution.
Step 6: Quality Control
Quality control checks are performed at various stages throughout the manufacturing process to ensure product quality and compliance with WHO GMP guidelines. Samples from each batch undergo thorough testing in our quality control laboratory for purity, potency, sterility, and stability. Only batches that meet our strict quality standards are released for distribution.
Step 7: Storage and Distribution
The finished Pantoprazole Injection vials are stored in temperature-controlled warehouses to maintain product stability until distribution. Our logistics team ensures timely product delivery to healthcare facilities, pharmacies, and distributors worldwide, adhering to strict cold chain requirements when necessary.
Conclusion Den Mark Pharmaceuticals Pvt. Ltd. is committed to producing top-quality Pantoprazole Injection 40 mg by WHO GMP guidelines. Our comprehensive manufacturing process prioritizes product quality, safety, and efficacy, from raw material procurement to distribution. Adhering to strict quality standards and implementing robust quality control measures ensures patients receive pharmaceutical products they trust to improve their health and well-being.