Process Validation Ointment

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

This is ready to use Process Validation of Ointment.

Regards

Ointment Process Validation.doc (451.0 KB)

2

Please can any body help me and send a tamp let of process validation to me ?
thank you

3

You have Oral Tablets, Capsules, Syrups and Ointment formats.
You must look this place and just download.

4

I try to download this file but it dose not work, please any one can put another copy of this file.

Thank you

5

I will send to your email address now.

[quote=nour_elnakeeb]I try to download this file but it dose not work, please any one can put another copy of this file.

Thank you[/quote]

6

Respected sir,
I have one doubt regarding process validation, if a new batch we are validating, first two batches are for example 4.0 lakhs each, but the last batch is 2.0 lakh only. How can we validate the process.

7

thaks a lot it is really good work god bless you…

8

Where do you find limits for assay?
Thx:D

9

thank you durga for the ointment process validation.

its very helpful for me

asit

10

yes Mr,
As per validation definition given in FDA guideline there should be minimum three consecutive batches to complete the validation, in your case validation is not completed ,you should validate three batches of 4.0 Lac if three batches not come you should close the two validation batches with justification and whenever 4.0 lac batch size batch will come in your facility you should start validation from initialy consider Ist batch. you should have in mind that three batches should be consecutive for completeing the validatio exercise.
Thanks
Anil Singh