I'm doing a project plan for new formula which included new active ingredient. The preparation of active ingredient will be included in this project. I was asking about a validation method for the manufacturing of this newly active ingredient and if there is any health organization make a regulation to organize this process?
You can follow ICH guidelines for validation and other GMP guidelines for API
ICH has guidelines for quality, safety, efficacy and miscellaneous guidelines
Hi,
Different countries have different guidelines, so needs to go through the guideline where you are going to register your product, WHO, MHRA,TGA etc also provide guidelines.
if there is well established system in your country regarding validation protocols than you should follow it other wise follow Validation protocols mentioned by FDA.
- Badges
- Science topic
- Similar topics
- Chemistry
- Pharmacology
- Pharmaceuticals