Guidlines on how to write IQ,OQ,PQ and process validation protocols

GOOD VALIDATION PRACTICE (cGVP)
1

dear colleagues

Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you.

best regards
Mediana

WHOsprotokol.pdf (240.2 KB)

2

Excellent post.

Really helpful

Many thanks

3

Excellent. Helpful in many objectives.

Best Regards,

Pravat Kumar Tripathy

4

[quote=me_av@hotmail.com]dear colleagues

Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you.

best regards
Mediana[/quote]

Thanks for sharing.

D.Raghavendra.

5

I was in need of the information given by u.
It really helped me a lot.
thanks a lot…

Best regards
Arif

6

thanks a lot,
Regards,

Ravi.B

7

Mediana,
Thank you so much. Most of information contained herein is part of what I’ve been looking for.
J Musumba

8

This is WHO’s document.
It’s good.

9

thanks… A Blessing…I need this…

10

Thank you , you had given very good information to us.

11

I just happened onto this document when I most needed it. Thanks for posting it.

12

Thanks for sharing,
Really very much Helpful .

Regards,
Prashant M

13

Thanks for sharing!
It is good information to me!

I has view quickly,it is a pity that "the examples comprising this Annex were pasted in from original hard copies,
and are not available in electronic format"

[quote]
Appendix 5: Validation protocols contributed by a vaccine manufacturer
Massachusetts Public Health Biologic Laboratories
1) Master Validation Plan for the Vaccine Production Facility .............................. 97
2) Validation of cleaning processes using swabs to sample for residual protein 104
3) Master File for Validations of Sterile Fill with Tryptic Soy Broth .................. 108
4) Requirements for Validating Assays in Quality Control .................................. 145
([COLOR="Red"]the examples comprising this Annex were pasted in from original hard copies,
and are not available in electronic format[/color])[/quote]
14

[Atached is a WHO guidelines on how to write IQ, OQ, PQ and process validation. I thought of sharing this with you.
sir that file not open pl share with me

best regards
rakesh

15

excellent, thanks for that

16

Its a good trend to share the available guidelines. I request all members to answer a question with valid reference as well.

17

thank you a lot :slight_smile:

18

Thank you so much for this sharing.
ıt is really useful document for me.
Best regards

19

sir,
will we done process validation study for clinical trial batches. it is required or not required.
or
process validation is requiment for first three commertial batches.
Pls. clarify

Anil Saxena

20

[quote=anil saxena]sir,
will we done process validation study for clinical trial batches. it is required or not required.
or
process validation is requiment for first three commertial batches.
Pls. clarify

Anil Saxena[/quote]

Process validation guidelines do not address for Clinical trial batches, as these are mostly unique with its process, formulations and batch sizes. So for each trial require a protocol and data need to be generated of its own. However for phase 3 clinical trials the Formula should be established and process must be validated like a commercial batch.