Effective Healthcare Solutions by manufacturing Rosuvastatin tablets, adhering to WHO GMP guidelines, are implemented by Den Mark Pharmaceuticals Pvt. Ltd.
1. Starting Materials and Documentation:
- All starting materials will be procured from approved vendors with valid Certificates of Analysis (CoA).
- A master batch record (MBR) specifying components, quantities, and manufacturing procedures will be established for each Rosuvastatin tablet strength.
2. Weighing and Blending:
- A designated weighing area will be used to accurately weigh Rosuvastatin calcium (active ingredient) and excipients like binders, fillers, disintegrants, and lubricants according to the approved MBR.
- We will employ a calibrated blending machine to ensure homogenous mixing of all components for a predetermined time.
3. Granulation (Optional):
Depending on the formulation, a wet or dry granulation process may be implemented.
- Wet granulation involves adding a granulating liquid to create granules, which are then dried and milled to a uniform size.
- Dry blending directly compresses the powder mixture into tablets.
4. Compression:
- The homogenous blend or granules will be transferred to a high-speed rotary tablet press.
- The press will be equipped with appropriate tooling to produce tablets with the specified dimensions and target weight.
- In-process controls will be implemented to monitor and ensure consistent tablet weight and physical characteristics.
5. Quality Control:
- Samples will be collected throughout the process for quality control testing.
- This will include tests for weight variation, tablet hardness, friability, disintegration time, and dissolution profile.
- The Rosuvastatin content will be quantified using validated analytical methods.
- Only batches meeting all pre-defined specifications will be approved for further processing.
6. Coating (Optional):
- An optional film coating may be applied to the tablets for taste masking, moisture protection, or controlled drug release.
- A coating pan will be used to apply the coating solution uniformly.
- The thickness and quality of the coating will be monitored and controlled.
7. Packaging and Labelling:
- Approved packaging materials will be used to ensure product protection during storage and transportation.
- Labels will be affixed with product information, including brand name, dosage strength, expiry date, and batch number, complying with regulatory requirements.
8. Quarantine and Release:
- The finished product will be placed under quarantine until the final Certificate of Analysis (CoA) is generated, confirming all quality parameters are met.
- The batch will only be released for distribution after approval by the Quality Assurance department.
9. Documentation and Record Keeping:
- Detailed records of all manufacturing steps, including raw material receipts, batch production records, and quality control results, will be maintained for future reference and regulatory audits.
Commitment to Quality: With International Pharmaceutical Trade Partners - Den Mark Pharmaceuticals Pvt. Ltd. is committed to manufacturing high-quality Rosuvastatin tablets that adhere to the highest GMP standards. This ensures patient safety and efficacy of the medication.