Checkpoints to review the process validation for the 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.
12. Is the granulation adequately blended to achieve the desired distribution of active ingredients 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:
15. For color uniformity, is there a provision for a color uniformity test?
16. Is the batch size of blend within the performance qualification (working volume) of the 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?
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.
12. Is the granulation adequately blended to achieve the desired distribution of active ingredients 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 many 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 a color uniformity test?
16. Is the batch size of blend within the performance qualification (working volume) of the 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?
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