Diclofenac Tablets

2. Weighing and Blending:

• A validated weighing procedure ensures accurate measurement of Diclofenac Sodium API and excipients (e.g., lactose, microcrystalline cellulose, disintegrants, lubricants).
• Blending is performed in a closed blending system to minimize dust and cross-contamination.

3. Granulation:

• The weighted blend undergoes a granulation process (e.g., wet or dry granulation) to improve flowability and achieve uniform tablet weight.
• Granule size distribution and uniformity are tested to ensure proper compression characteristics.

4. Milling and Sieving:

• Granules are milled to a desired size for tableting.
• The milled material is passed through a sieve to remove oversized or undersized granules, ensuring consistent tablet weight and disintegration.

5. Lubrication:

• A lubricant (e.g., magnesium stearate) is added to the milled blend to prevent sticking during compression.
• The final blend is mixed uniformly to ensure proper lubrication.

6. Tablet Compression:

• The lubricated blend is fed into a validated tablet compression machine.
• The machine compresses the blend into tablets with consistent weight, size, and shape.
• In-process controls monitor tablet weight and dimensions throughout the compression process.

7. Deblistering and Inspection:

• Compressed tablets are de-blistered and visually inspected for defects (chipping, capping).
• Automated or manual weight checks ensure each tablet meets the pre-defined weight specifications.

8. Packaging:

• Approved tablets are counted electronically and filled into pre-printed blister packs with desiccant pouches for moisture control.
• Following regulatory requirements, cartons are labeled with product information, batch number, expiry date, and Den Mark Pharmaceuticals branding.

9. In-Process and Finished Product Testing:

• Samples are collected for testing throughout the manufacturing process.
• Tests include:
  • Diclofenac content: Verifies the presence of the correct amount of Diclofenac Sodium.
  • Disintegration: Ensures tablets break down within specified time limits for proper drug release.
  • Dissolution: Measures the rate and extent of drug release from the tablet.
  • Uniformity of weight: Evaluate the consistency of individual tablet weights.
  • Other tests May be required depending on the specific formulation and regulatory requirements.

10. Batch Release and Storage:

• Only batches that meet all pre-defined specifications are released for pharmaceutical distribution.
• Released batches are stored under controlled conditions (temperature, humidity) to maintain product quality.

11. Documentation and Record Keeping:

• All manufacturing steps are documented, including raw material usage, process parameters, and test results.
• Records are maintained for a pre-determined period as per GMP guidelines.