Audio only
Eu Gmp Annex 13 (Investigational Medicinal Products , Complexity Meets Reality)
By Unknown AuthorNarrated by Rango DietrichLength1h 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
2Preface
3Principle
4Notes - Non-Investigational Medicinal Product
5Notes - Manufacturing Authorisation and Reconstitution
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6Glossary - Blinding
7Glossary - Clinical Trial
8Glossary - Comparator Product
9Glossary - Investigational Medicinal Product
10Glossary - Investigator
11Glossary - Manufacturer or Importer of Investigational Medicinal Products
12Glossary - Order
13Glossary - Product Specification File
14Glossary - Randomisation
15Glossary - Randomisation Code
16Glossary - Shipping
17Glossary - Sponsor
18Quality Management - 1. Quality System
19Quality Management - 2. Product Specifications and Manufacturing Instructions
20Personnel - 3. Personnel Training
21Personnel - 4. Qualified Person
22Premises and Equipment - 5. Cross Contamination
23Documentation - Specifications and Instructions - 6. Specifications, Manufacturing Formulae
24Documentation - Specifications and Instructions - 7. Rationales for Changes
25Documentation - Order - 8. Order
26Documentation - Product Specification File - 9. Product Specification File
27Documentation - Manufacturing Formulae and Processing Instructions - 10. Written Instructions
28Documentation - Manufacturing Formulae and Processing Instructions - 11. Product Specification File
29Documentation - Packaging Instructions - 12. Packing in an Individual Way
30Documentation - Processing, Testing and Packaging Batch Records - 13. Batch Records
31Documentation - Processing, Testing and Packaging Batch Records - 14. Retaining Periods
32Production - Packaging Materials - 15. Guard Against Unintentional Unblinding
33Production - Manufacturing Operations - 16. Critical Parameters and In-Process Controls
34Production - Manufacturing Operations - 17. Validation of Production Processes
35Production - Manufacturing Operations - 18. Validation of Aseptic Processes
36Production - Principles Applicable to Comparator Product - 19. Modifications of Comparators
37Production - Principles Applicable to Comparator Product - 20. Expiry Date for Comparators
38Production - Blinding Operations - 21. Achieving the Blind and Emergency Unblinding
39Production - Randomisation Code - 22. Handling of Randomisation Code
40Production - Packaging - 23. Risk of Product Mix Up
41Production - Packaging - 24. Complexity of Packaging and Labelling
42Production - Packaging - 25. Ensure Good Condition During Transport and Storage
43Production - Labelling - 26. Information On Labels
44Production - Labelling - 27. Package Leaflet
45Production - Labelling - 28. Languages
46Production - Labelling - 29. Special Requirements Primary Package Together With Secondary Packaging
47Production - Labelling - 30. Special Requirements - Blister Packs or Small Units
48Production - Labelling - 31. Symbols or Pictograms
49Production - Labelling - 32. Simplified Provisions
50Production - Labelling - 33. Change of Use-By Date
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