Rosuvastatin tablets

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.