Den Mark Pharmaceuticals Pvt. Ltd. is a top Drug Manufacturing Company committed to manufacturing top-quality pharmaceutical products adhering to the guidelines set by the World Health Organization (WHO) Good Manufacturing Practices (GMP). In line with this commitment, the capsule filling process for Clopidogrel + Aspirin Capsules is meticulously designed to ensure the highest standards of quality, safety, and efficacy.
Process:
1. Preparation:
- Weighing: Both Clopidogrel and Aspirin powders are accurately weighed according to the predetermined formulation, following aseptic techniques within a designated weighing area.
- Calibration: Weighing balances are routinely calibrated with certified weights to ensure accuracy.
- Documentation: All weighings are documented in the batch production records.
2. Milling and Blending:
- Milling: Individually, Clopidogrel and Aspirin powders are milled to a uniform particle size using a sanitized grinding mill. This ensures proper distribution of the drug within the capsule and consistent dissolution rates.
- Blending: The milled powders are transferred to a sanitized blender and mixed uniformly with the specified amount of lubricant. Blending time is optimized to achieve a homogeneous mixture without segregation.
3. Capsule Filling:
- Capsule Inspection: Empty capsules are inspected visually for any defects like cracks or chips before use.
- Capsule Filling Machine: The blended formulation is carefully loaded into a validated capsule-filling machine. The machine fills the capsules with the powder mixture at a predetermined weight, ensuring capsule uniformity.
- In-process Controls: Capsule weight and filling accuracy are continuously monitored during the process. Samples are periodically withdrawn and checked for weight uniformity as per the sampling plan.
4. Metal Detection:
- Metal Detector: After filling, all capsules pass through a metal detector to ensure no foreign metallic objects are present within the capsules.
5. Packing and Labeling:
- Packing: The filled capsules are transferred to a designated packaging area. A counting machine ensures the accurate number of capsules placed into pre-labeled bottles.
- Labels: Labels must meet all regulatory requirements and include product name, ingredients, dosage, expiry date, batch number, and Den Mark Pharmaceuticals Pvt. Ltd. as the manufacturer.
6. Quality Control:
- Samples: Representative samples from each batch are retained for further testing by the quality control department. Testing ensures the capsules meet all specifications for weight uniformity, content uniformity, dissolution rate, and other quality parameters as per the product registration documents.
- Batch Release: Only batches that pass all quality control tests are released for final packaging and distribution.
Documentation
- All stages of the manufacturing process are documented as per GMP guidelines. This includes raw material receipts, weight records, blending records, capsule filling machine settings, in-process control data, and final product test results.
Cleaning and Sanitation:
- All equipment and the manufacturing area are cleaned and sanitized according to a predefined schedule to prevent contamination.
Den Mark Pharmaceuticals Pvt. Ltd. sticks to continual improvement of its pharmaceutical manufacturing processes. This capsule-filling process is reviewed and updated regularly to ensure ongoing compliance with WHO GMP and to produce the highest quality Clopidogrel + Aspirin capsules for patient safety and well-being.