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Eu Gmp Annex 13 (Investigational Medicinal Products , Complexity Meets Reality)
By Unknown AuthorNarrated by Rango Dietrich
Length1h 35m
About this audiobook
Get to know more about the scope and limits of complex regulatory guidelines! PharmAudio audiobook Understanding Pharma Guidelines EU GMP ANNEX 13 Investigational Medicinal Products Complexity Meets Reality Read by Alison Rippier, Dr Joseph Rippier and Dr Rango Dietrich Implementing pharmaceutical regulatory guidelines is a complex matter. Reading these regulatory procedures, understanding them and putting them into practice not only requires time but often also assistance – and here it is: the current regulatory guidelines as an audiobook with qualified comments based on long years of industrial and consulting experience. The requirements stipulated by GMP (Good Manufacturing Practice) for the preparation of investigational medicinal products are regulated in Annex 13. Many interfaces to GCP (Good Clinical Practice), the QP (Qualified Person) and to the entire supply chain have to be translated professionally into real processes. Dr Rango Dietrich provides comments on the most important texts, drawing on over twenty years of experience, to make the texts easier for the listener to understand.
Audiobook details
GenreEducation and Learning
Length1 hr 35 mins
Narrated byRango Dietrich
FormatAudiobook
Publish dateMar 14, 2014
LanguageEnglish
Table of contents
1Opening Credits
38Production - Blinding Operations - 21. Achieving the Blind and Emergency Unblinding
2Preface
39Production - Randomisation Code - 22. Handling of Randomisation Code
3Principle
40Production - Packaging - 23. Risk of Product Mix Up
4Notes - Non-Investigational Medicinal Product
41Production - Packaging - 24. Complexity of Packaging and Labelling
5Notes - Manufacturing Authorisation and Reconstitution
42Production - Packaging - 25. Ensure Good Condition During Transport and Storage
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6Glossary - Blinding
43Production - Labelling - 26. Information On Labels
7Glossary - Clinical Trial
44Production - Labelling - 27. Package Leaflet
8Glossary - Comparator Product
45Production - Labelling - 28. Languages
9Glossary - Investigational Medicinal Product
46Production - Labelling - 29. Special Requirements Primary Package Together With Secondary Packaging
10Glossary - Investigator
47Production - Labelling - 30. Special Requirements - Blister Packs or Small Units
11Glossary - Manufacturer or Importer of Investigational Medicinal Products
48Production - Labelling - 31. Symbols or Pictograms
12Glossary - Order
49Production - Labelling - 32. Simplified Provisions
13Glossary - Product Specification File
50Production - Labelling - 33. Change of Use-By Date
14Glossary - Randomisation
51Quality Control - 34. Testing
15Glossary - Randomisation Code
52Quality Control - 35. Quality Control to Comply With Product Specification File
16Glossary - Shipping
53Quality Control - 36. Samples to Be Retained
17Glossary - Sponsor
54Quality Control - 37. Storage Location of Reference and Retention Samples
18Quality Management - 1. Quality System
55Release of Batches - 38. Release of Investigational Medicinal Products
19Quality Management - 2. Product Specifications and Manufacturing Instructions
56Release of Batches - 39. Elements That Need to Be Considered By Qualified Person
20Personnel - 3. Personnel Training
57Release of Batches - 40. Assessment of Each Batch for Certification
21Personnel - 4. Qualified Person
58Release of Batches - 41. Reference to Annex 16
22Premises and Equipment - 5. Cross Contamination
59Release of Batches - 42. Packaging or Labelling At the Investigator Site
23Documentation - Specifications and Instructions - 6. Specifications, Manufacturing Formulae
60Shipping - 43. Two-Step Release Procedure
24Documentation - Specifications and Instructions - 7. Rationales for Changes
61Shipping - 44. Shipping of Investigational Products
25Documentation - Order - 8. Order
62Shipping - 45. Decoding Arrangements
26Documentation - Product Specification File - 9. Product Specification File
63Shipping - 46. Inventory of the Shipments
27Documentation - Manufacturing Formulae and Processing Instructions - 10. Written Instructions
64Shipping - 47. Transfers of Investigational Medicinal Products from One Trial Site to Another
28Documentation - Manufacturing Formulae and Processing Instructions - 11. Product Specification File
65Complaints - 48. Complaint Related to the Quality of the Product
29Documentation - Packaging Instructions - 12. Packing in an Individual Way
66Recalls and Returns - Recalls - 49. Procedures
30Documentation - Processing, Testing and Packaging Batch Records - 13. Batch Records
67Recalls and Returns - Recalls - 50. Communication of Recalls for Comparators
31Documentation - Processing, Testing and Packaging Batch Records - 14. Retaining Periods
68Recalls and Returns - Returns - 51. Return On Agreed Conditions
32Production - Packaging Materials - 15. Guard Against Unintentional Unblinding
69Recalls and Returns - Returns - 52. Identification and Storage
33Production - Manufacturing Operations - 16. Critical Parameters and In-Process Controls
70Destruction - 53. Destruction of Unused and or Returned Investigational Medicinal Products
34Production - Manufacturing Operations - 17. Validation of Production Processes
71Destruction - 54. Recording of Destruction Operations
35Production - Manufacturing Operations - 18. Validation of Aseptic Processes
72Destruction - 55. Certificate of Destruction
36Production - Principles Applicable to Comparator Product - 19. Modifications of Comparators
73Closing Credits
37Production - Principles Applicable to Comparator Product - 20. Expiry Date for Comparators
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