Checklist to Review Tablet Process Validation : Pharmaceutical Guidelines

Checklist to Review Tablet Process Validation

Checkpoints to review the process validation for tablet manufacturing process.
1. Is the reason for the presence of each ingredient in the formula provided?
2. Are the normal properties of each ingredient mentioned? Are these properties used or changed in the formula under study.
3. Are the characteristics of the initial powder blends, the wet and/or dry granulations and the final blends mentioned?
4. Is the density – ‘loose’ and ‘tap’ determined?
5. Is the particle size distribution determined?
6. Is the surface area determined?
7. Are the flow properties, e.g. contact angle determined?
8. Are the moisture content, if applicable determined?
9. Are all the processing steps needed for the initial scale-up determined?
10. Is the optimal blending time based MFR.

11. Are the tests used to assess the uniformity of the final product determined? Content uniformity, weight variation testing?
12. Is the granulation adequately blended to achieve the desired distribution of active ingredient in the overall mix (e.g. direct compression formulations) or simply to add a tablet lubricant to the final stage?
13. Is the time of “unmixing” i.e., time to lose uniformly determined? – Powder blends and granulations can become segregated on blending as a result of particle size or density difference.
14. Are the following critical characteristics of blend checked:

  • Bulk density – this will have a significant bearing on tablet thickness and could affect product uniformity
  • Particle size distribution - a key parameter affecting may product characteristics.
  • Moisture, if applicable – can be important as related to product physical and chemical stability

15. For color uniformity, is there a provision for color uniformity test?
16. Is the batch size of blend within the performance qualification (working volume) of blender?
17. Is the binder concentration validated? Density, viscosity etc. could be the probable parameter for this.
18. Is the density of wet granulation and dry powder compared?

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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