Aceclofenac + Paracetamol + Serratiopeptidase Tablets

2. Weighing and Blending:

• A validated weighing procedure will be followed to measure each raw material according to the approved formulation accurately of Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg).
• All materials will be transferred to a blender and mixed for a predetermined time to achieve uniform distribution.

3. Granulation (Wet or Dry):

• The chosen method (wet or dry granulation) will depend on the specific characteristics of the raw materials.
• Wet granulation involves adding a granulating solution to achieve optimal moisture content for granule formation. The granules will then be dried and sized.
• Dry granulation involves compacting the powder blend through rollers and milling the resulting compacts into granules.

4. Milling and Sifting:

• Granules will be milled to a uniform size using a suitable mill for manufacturing process of Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg).
• The milled granules will be passed through a designated sieve to ensure consistent particle size distribution.

5. Lubrication:

• Calculated quantities of lubricants (e.g., magnesium stearate) will be added to the milled granules and blended for a specific time to ensure even distribution of Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg).
• Lubrication minimizes friction during tableting and facilitates smooth ejection of tablets from the compression machine.

6. Tablet Compression:

• The lubricated blend will be fed into a validated tablet compression machine.
• The machine will be set to compress the blend into tablets with the specified weight, shape, and dimensions of the Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg).
• In-process controls will be performed throughout the compression process to ensure consistent tablet quality.

7. Post-Compression Inspection:

• Compressed tablets will be subjected to various quality control tests per specifications, including weight variation, hardness, friability, and disintegration of Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg).
• Non-conforming tablets will be rejected.

8. Coating (Optional):

• An optional film coating may be applied for moisture protection, taste masking, or aesthetics.
• The coating process will involve spraying a film-forming solution onto the tablets in a coating pan.
• The coating process parameters will be controlled and monitored to achieve a uniform and consistent coating of Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg).

9. Packaging:

• Approved Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg) will be counted and filled into pre-labeled containers (e.g., blisters, bottles) using validated counting machines.
• Packaging materials will comply with GMP regulations and protect the Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg) from light, moisture, and contamination.

10. Labeling:

• Labels will be applied to each container with all mandatory information per regulatory requirements, including product name, ingredients, dosage instructions, expiry date, and batch number.

11. Quarantine and Release:

• Finished Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg) batches will be quarantined until final product testing is complete.
• Testing will encompass physical, chemical, and microbiological parameters per specifications under manufacturing process.
• Batches meeting all specifications will be released for distribution of Aceclofenac + Paracetamol + Serratiopeptidase Tablets (100mg/325mg/15mg).

12. Documentation and Record Keeping:

• All manufacturing steps will be documented, including raw material receipt, production processes, in-process controls, packaging, and quality control testing.
• Records will be maintained for a predefined period as per GMP guidelines.