Manufacturing QC and QA
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Manufacturing QC and QA
![EMERGING ISSUES AND CONSIDERATIONS IN MANUFACTURING QUALITY CONTROL AND ASSURANCE OF DRUG PRODUCTS ,[object Object],[object Object],[object Object],This presentation does not necessarily represent the official position of FDA](https://image.slidesharecdn.com/cmcpresentation-fda-yi-tsong-1232127852158652-2/85/Manufacturing-QC-and-QA-1-320.jpg)
![Three Dimensions of the Critical Path ,[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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Manufacturing QC and QA
- 3. Working in Three Dimensions on the Critical Path
- 4. Statistical Chemical Manufacturing Control and Assurance Programs Shelf Life Determination & Stability Acceptance Tests of Finished Product PAT (Process Analytical Technology) In Vitro Equivalence Tests
- 9. Japan 2-Stage Dissolution Test Rule Step 1, 6 tablets No Accept Yes Step 2, additional 6 tablets Yes Accept No Reject Tsong, Shen, Shah, JBS, 2004
- 10. Tsong, Shen, Shah, JBS, 2004
- 11. 3-Stage Dissolution Acceptance Test Based on Sequential Tolerance Interval Step 1, 6 tablets No Accept Yes Step 2, additional 6 tablets Yes Accept Step 3, additional 12 tablets Yes No Reject Accept Tsong, Shen, Shah, JBS, 2004
- 12. Tsong, Shen, Shah, JBS, 2004
- 13. Tsong, Shen, Shah, JBS, 2004
- 14. Tsong, Shen, Shah, JBS, 2004
- 15. Tsong, Shen, Shah, JBS, 2004
- 16. Tsong, Shen, Shah, JBS, 2004
- 17. FDA 2-Stage Delivery Dose Uniformity Acceptance Test Tsong & Shen, 2004
- 18. Step 1, 10 tablets No Accept Yes NMT 1 outside 85-115% All 10 within 75-125% Yes Reject No Step 2, additional 20 tablets NMT 1 outside 85-115% All 30 within 75-125% RSD 7.8% Yes Reject Accept All 10 within 85-115% RSD 6% No USP <905>, Content Uniformity Test (n = 30 units) Tsong, Shen, JBS, 2006
- 23. Typical Solid Dosage Process Wet Granulation Milling/ Sizing Blending Tablet Press Coating Inspection & Release Cogdill, et al, Fall Tech. Conf., 2004 FB Drier Dispensory PAT PAT PAT PAT PAT PAT PAT
- 28. Blend Uniformity & PAT Univariate Testing to Document Quality Approach Multivariate Quality-by Design Approach Traditional test methods At-line test methods On- and/or At-line test methods for all critical components and processes Current PQRI proposal and draft Guidance Draft Guidance may include information on the use of NIR methods Proposed PAT Guidance Incentive? Higher efficiency Lower “risk” leading to lower regulatory concern Ajaz Hussain, AAPS 39th Pharm. Technologies Conf., Jan. 2004
- 33. Cogdill, et al, Fall Tech. Conf., 2004 * Blender speed measured in rpm 12.8 3% 60% XVI 12.8 7% 60% XV 20.3 3% 60% XIV 12.8 11% 60% XIII 20.3 7% 60% XII 20.3 7% 60% XI 12.8 7% 60% X 20.3 11% 60% IX 20.3 3% 60% VIII 12.8 11% 20% VII 20.3 11% 20% VI 20.3 7% 20% V 12.8 7% 20% IV 20.3 3% 20% III 12.8 11% 20% II 12.8 3% 20% I Blender Speed * Salicylic acid Concentration Humidity Experimental Conditions Order
- 35. Results P = 0.0002 P = 0.002 P = 0.0331 Cogdill, et al, Fall Tech. Conf., 2004
- 41. Particle Size Distribution Profile Equivalence Test of Inhaler Products
- 42. Particle Size Distribution Profile Equivalence Test of Inhaler Products
- 43. Particle Size Distribution Profile Equivalence Test of Inhaler Products
- 46. Thank You For Your Interest!!!