SeerPharma Pty Ltd :: DISCover web-based training :: QC 6: Pharmaceutical Sampling Plans

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QC 6: Sampling Plans

Description: This module discusses the special problems associated with production, whether active or inactive "chemical" materials, printed or unprinted packaging materials, in-process materials, process water, or finished product. It reviews the theory and application of statistical and practical sampling plans.

Price: $239 (AUD)

(Australian customers, please add GST.)

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COURSE OUTLINE

INTRODUCTION TO SAMPLING PLANS
1. Introduction
2. Purpose of sampling
3. Sampling requirments
4. Sampling steps
5. Sampling plans
6. Review

READING ATTRIBUTE SAMPLING PLANS
7. Introduction
8. Defining an attribute
9. AQL I
10. AQL II
11. Parameters I
12. Parameters II
13. Parameters III
14. Reading plans I
15. Reading plans II
16. Reading plans III
17. Try some sampling plans
18. Review

CGMP REQUIREMENTS FOR CHEMICALS
19. Introduction
20. Chemicals requirements
21. Supplier qualification
22. Chemical testing plans
23. Microbial testing plans
24. Review

CGMP REQUIREMENTS FOR PRINTED MATTER
25. Printed matter requirements
26. Review

SAMPLING TECHNIQUES AND POOLING
27. Introduction
28. Content uniformity
29. Liquids sampling issues
30. Pooling/compositing rules
31. Sampling frequency
32. Zero Acceptance Number
33. Review

TARGETED SAMPLING PLANS
34. Introduction
35. Limitations
36. Targeted sampling
37. Water samples
38. Sampling points
39. Review

CONCLUSION
40. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Describe the considerations for setting up sampling plans
Read and interpret an attribute sampling plan
List special cGMP requirements for sampling chemicals
List special cGMP requirements for sampling printed matter and components
State the cGMP expectations for sample protection and pooling
Set up targetted sampling plans for a purified/WFI water system

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