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10 Cards in this Set
- Front
- Back
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ApI Requirements |
- Must be of desired standard and purity. - suppliers must be qualified. ( always provide consistent quality and purity of API |
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Methods used to manufacture API: |
-Chemical Components. - Recover from natural sources. - Cell /Culture Fermentation. |
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Equipment to manufacture API must be: |
-Appropriate design and adequate size. - must be used with its qualified range. - should be appropriately identified: * name and model number. * S/N *maintenance and calibration date. |
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Storage and Distribution To Production. |
- Materials must be segregated from other materials. (ApIs from non ApIs). - Materials under investigation are quarantine and identified as such. - Only QA released materials can be used in production.
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General Controls |
- Approved specification of materials.( APIs and Excipients). - Test methods are validated and approved. - APIs should be enrolled on a permanent stability study to support shelf life and retest date. |
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In- process Control |
Should be done during manufacturing process in between steps. Test to be conducted are: * LOD * Blend Uniformity. * Tablet weight and weight variation. * Friability. *Hardness. |
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Validation. |
-Equipment Qualification. ( IQ, OQ, PQ) - Process Validation. - Cleaning Validation. - Analytical Method Validation. - In-process control test procedures qualified for reproducibility. |
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Advantages of Direct Compression. |
- Fewer processing steps. -processing without moisture and heat therefore fewer stability problem. - Rapid and most direct method of tablet compression. |
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Disadvantages of Direct Compression |
- Possibility of lot to lot variation due to differences in PSD, flow ability, inherent moisture of excipients. - Higher risk of content uniformity failures in low dose products. - Lack of moisture can cause static charges that can result in unbending. |
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Advantages of Dry Granulation. |
- Improves flow by increase particles size. - Improves uniformity of powder density. - Improves cohesion during compression. |
