Pharmaudio Eu Gmp Annex 13 English original text (incl. comments in English)

Rango DietrichMarch 14, 2014
Comedy/SpokenWord/Other℗ 2014 Pharmaudio Guidelines
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Songs
1
Opening Credits0:49
2
Preface3:09
3
Principle4:30
4
Notes - Non-Investigational Medicinal Product2:32
5
Notes - Manufacturing Authorisation and Reconstitution2:46
6
Glossary - Blinding1:15
7
Glossary - Clinical Trial0:48
8
Glossary - Comparator Product0:11
9
Glossary - Investigational Medicinal Product0:53
10
Glossary - Investigator0:31
11
Glossary - Manufacturer or Importer of Investigational Medicinal Products0:25
12
Glossary - Order0:24
13
Glossary - Product Specification File0:50
14
Glossary - Randomisation0:31
15
Glossary - Randomisation Code0:10
16
Glossary - Shipping0:10
17
Glossary - Sponsor0:39
18
Quality Management - 1. Quality System0:24
19
Quality Management - 2. Product Specifications and Manufacturing Instructions0:42
20
Personnel - 3. Personnel Training0:57
21
Personnel - 4. Qualified Person0:56
22
Premises and Equipment - 5. Cross Contamination1:26
23
Documentation - Specifications and Instructions - 6. Specifications, Manufacturing Formulae1:02
24
Documentation - Specifications and Instructions - 7. Rationales for Changes1:03
25
Documentation - Order - 8. Order1:52
26
Documentation - Product Specification File - 9. Product Specification File2:31
27
Documentation - Manufacturing Formulae and Processing Instructions - 10. Written Instructions0:35
28
Documentation - Manufacturing Formulae and Processing Instructions - 11. Product Specification File1:06
29
Documentation - Packaging Instructions - 12. Packing in an individual Way1:38
30
Documentation - Processing, Testing and Packaging Batch Records - 13. Batch Records0:30
31
Documentation - Processing, Testing and Packaging Batch Records - 14. Retaining Periods0:44
32
Production - Packaging Materials - 15. Guard Against Unintentional Unblinding0:58
33
Production - Manufacturing Operations - 16. Critical Parameters and in-Process Controls1:15
34
Production - Manufacturing Operations - 17. Validation of Production Processes1:22
35
Production - Manufacturing Operations - 18. Validation of Aseptic Processes1:08
36
Production - Principles Applicable to Comparator Product - 19. Modifications of Comparators0:24
37
Production - Principles Applicable to Comparator Product - 20. Expiry Date for Comparators1:53
38
Production - Blinding Operations - 21. Achieving the Blind and Emergency Unblinding1:07
39
Production - Randomisation Code - 22. Handling of Randomisation Code1:36
40
Production - Packaging - 23. Risk of Product Mix Up0:26
41
Production - Packaging - 24. Complexity of Packaging and Labelling1:16
42
Production - Packaging - 25. Ensure Good Condition During Transport and Storage0:46
43
Production - Labelling - 26. Information On Labels4:29
44
Production - Labelling - 27. Package Leaflet0:27
45
Production - Labelling - 28. Languages0:32
46
Production - Labelling - 29. Special Requirements Primary Package Together With Secondary Packaging2:02
47
Production - Labelling - 30. Special Requirements - Blister Packs or Small Units1:42
48
Production - Labelling - 31. Symbols or pictograms0:17
49
Production - Labelling - 32. Simplified Provisions1:00
50
Production - Labelling - 33. Change of Use-By Date6:24
51
Quality Control - 34. Testing0:17
52
Quality Control - 35. Quality Control to Comply With Product Specification File0:53
53
Quality Control - 36. Samples to Be Retained3:08
54
Quality Control - 37. Storage Location of Reference and Retention Samples2:34
55
Release of Batches - 38. Release of Investigational Medicinal Products0:49
56
Release of Batches - 39. Elements That Need to Be Considered By Qualified Person4:25
57
Release of Batches - 40. Assessment of Each Batch for Certification3:15
58
Release of Batches - 41. Reference to Annex 160:30
59
Release of Batches - 42. Packaging or Labelling At the Investigator Site1:50
60
Shipping - 43. Two-Step Release Procedure2:02
61
Shipping - 44. Shipping of Investigational Products0:32
62
Shipping - 45. Decoding Arrangements0:23
63
Shipping - 46. Inventory of the Shipments0:28
64
Shipping - 47. Transfers of investigational medicinal products from one trial site to another1:41
65
Complaints - 48. Complaint Related to the Quality of the Product1:04
66
Recalls and Returns - Recalls - 49. Procedures0:29
67
Recalls and Returns - Recalls - 50. Communication of Recalls for Comparators0:51
68
Recalls and Returns - Returns - 51. Return On Agreed Conditions0:16
69
Recalls and Returns - Returns - 52. Identification and Storage0:43
70
Destruction - 53. Destruction of Unused and or Returned Investigational Medicinal Products0:23
71
Destruction - 54. Recording of Destruction Operations1:28
72
Destruction - 55. Certificate of Destruction0:45
73
Closing Credits0:37
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Additional Information

Tracks
73
Released
March 14, 2014
Label
℗ 2014 Pharmaudio Guidelines
File type
MP3
Access type
Streaming and by permanent download to your computer and/or device
Internet connection
Required for streaming and downloading
Playback information
Via Google Play Music app on Android v4+, iOS v7+, or by exporting MP3 files to your computer and playing on any MP3 compatible music player
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