Den Mark Pharmaceuticals Pvt. Ltd., Strictly follows to the guidelines set forth by the World Health Organization (WHO) Good Manufacturing Practices (GMP) to ensure the production of top-quality pharmaceuticals. Below is a detailed description of the capsule filling process for Omeprazole 20 mg + Domperidone capsules, providing precision, cleanliness, and efficacy.
Step 1: Pre-Production Preparation
- Raw Material Inspection: All raw materials, including Omeprazole, Domperidone, excipients, and capsule shells, undergo rigorous inspection and testing to meet quality standards.
- Equipment Calibration: Capsule filling machines, weighing scales, and other equipment are calibrated to ensure accuracy in dosage and filling.
- Cleaning and Sanitization: The manufacturing area, equipment, and utensils are thoroughly cleaned and sanitized to prevent contamination.
Step 2: Formulation Preparation
- Weighing and Mixing: Precise amounts of Omeprazole and Domperidone are weighed according to the formulation requirements. These active ingredients are mixed thoroughly with appropriate excipients using a blender to achieve homogeneity.
- Granulation (Optional): If required, granulation may be performed to improve flow properties and uniformity of the blend.
Step 3: Capsule Filling
- Capsule Shell Preparation: Empty capsule shells (size 0) made of suitable material (e.g., gelatin) are inspected for defects and loaded into the filling machine.
- Filling: The blend of Omeprazole, Domperidone, and excipients is accurately dispensed into the capsule shells using a dosing system that ensures uniformity of dosage.
- Tampering: After filling, the capsules gently tap or vibrate to settle the powder and avoid air pockets.
- Capping: The filled capsules are capped with the corresponding cap, ensuring a proper seal to prevent leakage or contamination.
- Weight Check: Randomly selected samples of filled capsules are weighed to verify uniformity of dosage.
Step 4: Quality Control
- Visual Inspection: Filled capsules are inspected for defects such as cracks, chips, or uneven filling.
- Disintegration Test: A sample of capsules is subjected to a disintegration test to ensure they disintegrate within the specified time frame.
- Dissolution Test: Another sample is tested for dissolution to confirm the release of Omeprazole and Domperidone within predetermined limits.
- Microbiological Testing: Samples are tested for microbial contamination to ensure product safety.
- Stability Testing: Stability studies are conducted to determine the product's shelf life under various conditions.
Step 5: Packaging and Labeling
- Blister Packing: Filled capsules are packed into blister packs, with appropriate labeling indicating product name, strength, batch number, manufacturing and expiry dates, and dosage instructions.
- Secondary Packaging: Blister packs are then packed into cartons for additional protection during storage and transportation.
- Labeling Compliance: All packaging materials are labeled in compliance with regulatory requirements and GMP standards.
Step 6: Documentation
- Batch Record: For traceability, a detailed batch record documenting each manufacturing process step, including deviations and corrective actions, is maintained.
- Quality Assurance Release: Only batches that meet all quality control specifications are released for distribution.
Den Mark Pharmaceuticals Pvt. Ltd.a Top Indian Pharma Company ensures that every step of the capsule filling process is carried out with precision, adherence to GMP guidelines, and a commitment to delivering safe and effective pharmaceutical products to patients worldwide.