Prospective validation of FDF (ointment) production

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Good evening all!
I have one question, could you please help me:
Can I use different manufacturer API in prospective validation of FDF (ointment) production? Or all three batches will be produced from one API?

May be you could suggest guidelines point where its is defined?

Thank You in Advance.

2

All validation batches should have same source of API. If source of API will change re-validation has to be executed.(REF: WHO Technical Report Series, No. 937, 2006, section 7.1

2 Likes
3

Thank you for your answer.
Could you please notify WHO ref. intranet address. I found this:
http://whqlibdoc.who.int/trs/who_trs_937_eng.pdf
. Are you think section 7.1 - Annex 7- validation ?

4

No. This isn’t

5

Good morning!
Could you please clarify in which document or annex it is written. If it is possible could you please to specify a web address.

Thank You in Advance.

6

Have a look.

7

I was thaught that it can be good to validate different API manufacturers during validation.
How can I revalidate if I didn’t finished validation?

8

You can cite ‘new’ validation requirements per process validation FDA (2011) and EU (2015). And ‘new’ analytical method validation per FDA (2015).

9

For me, hv to validate the different API manufacturer. meaning to say that to perform separate validation, 3 batches respectively.

10

Also, a better (not sure if its required) practice is to use multiple API lots from the same manufacturer during validation.