VICH: Guideline for Active Pharmaceutical Ingredients in Veterinary Medicinal Products

The draft guideline "Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products - VICH GL 60" of the VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) can still be commented on until the end of March 2024. Comments can be submitted via the U.S. FDA website, for example.

The VICH has been in existence since 1996 and is an association of the EU, the USA and Japan. It has set itself the task of harmonizing the requirements for the registration of veterinary medicinal products. In the course of this, VICH GL 60 (see above) has now been made available for public comment in Step 4.

The directive is divided into the following 21 chapters, most of which also have sub-chapters:

1. INTRODUCTION
2. QUALITY MANAGEMENT 
3. PERSONNEL
4. BUILDINGS AND FACILITIES
5. PROCESS EQUIPMENT
6. DOCUMENTATION AND RECORDS
7. MATERIALS MANAGEMENT 
8. PRODUCTION AND IN-PROCESS CONTROLS 
9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES
10. STORAGE AND DISTRIBUTION
11. LABORATORY CONTROLS
12. VALIDATION
13. CHANGE CONTROL
14. REJECTION AND RE-USE OF MATERIALS
15. COMPLAINTS AND RECALLS
16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)
17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELERS
18. SPECIFIC GUIDANCE FOR APIS MANUFACTURED BY CELL CULTURE/FERMENTATION
19. APIs FOR USE IN CLINICAL TRIALS
20. GLOSSARY
21. REFERENCES

You can view and comment on the draft guideline "Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products - VICH GL 60" on the U.S. FDA website, for example.