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