PV 4 New Chemical Entity

• Product Validation
• Section A
• Section B
• Section C
• Section D
• Section E
• Section P
• Section S
• Part III
• Part IV

·         Please refer Appendix 8.2 List of Prohibited and Restricted Excipients; and Appendix 8.3 Lists of Permitted and Restricted Colouring Agents    

• For each excipient ingredient included in a formulation must have a justifiable excipient role and shall be controlled by specifications.
• New excipient will require safety and/or other additional data to support the function in the product prior to addition into the Quest 3 database.
• Please enter function of excipients, e.g. sweetener, preservative, thickening agent, etc. which can be selected from the drop-down list.

How to Access Excipient in QUEST3+ System ? 

Product Registration >> New Application Form >> Product Validation >> Excipient