Guys

I am working in Generic Pharmaceutical company and I have been told to write summary report for IQ OQ AND PQ OF THE QUALIFIED WATER SYSTEM I have IQ OQ AND PQ report and data with me but I am looking for any format or example of the summary report I would really appreciate if anybody could provide guideline to generate report

Thanks in advance

:(

Guys

I am working in Generic Pharmaceutical company and I have been told to write summary report for IQ OQ AND PQ OF THE QUALIFIED WATER SYSTEM I have IQ OQ AND PQ report and data with me but I am looking for any format or example of the summary report I would really appreciate if anybody could provide guideline to generate report

Thanks in advance

:(

Guys

I would really appreciate your feed back response

Give people a chance to respond. The post was only yesterday. There will be responses on this post, so please be patient.

Did you complete any up-front specifications? Is there anything that your management approved/signed on the requirements for the validation?

Say in your up-front specifications, you stated something to the effect of this equipment will perform A, B, C, and X, Y, Z, and 1, 2, 3.

Then I would surmise your post-report should clarify A, B,C, X, Y, Z, and 1, 2, 3. You will not get overly technical in the report (that's what the raw data is for). You will submit to management a summary of how the requirements were satisfied, and the evidence to support that.

Did you complete any up-front specifications? Is there anything that your management approved/signed on the requirements for the validation?

Say in your up-front specifications, you stated something to the effect of this equipment will perform A, B, C, and X, Y, Z, and 1, 2, 3.

Then I would surmise your post-report should clarify A, B,C, X, Y, Z, and 1, 2, 3. You will not get overly technical in the report (that's what the raw data is for). You will submit to management a summary of how the requirements were satisfied, and the evidence to support that.

Thanks for kind response

I understand but I am looking for any specific example

bump.........
:(

I work in the blood industry where our summaries are seen by our countries regulatory body besides our own management team.
We put the following together
1. Executive summary discribing the overall purpose and scope of the validation
2. Background information if this is a change to an existing system.
3. Summary of the documents generated to qualify the process.
4. Results of the validation process. The conclusions of the validation process, tables and other information is tabulated here. Its gives an overall assesment of what was achieved. We also include the deficiencies encountered and how they were resolved. Here we give the conclusion and the limitations of the process if any.
5. Report approval.

How that helps some.

Don
5.

class08820, I understand that you are probably pretty anxious to get this, but please be patient. You are asking for borderline proprietary/ confidential files from a very limited audience.

What format is your deliverables before the summary report? Your summary report is just that, a summary of what you have done. Did you submit a validation plan to be approved by your management?

Thus, it seems a bit silly to provide a summary report that will not fit your scenario, or address the essential components of your study.

At the top of the Elsmar page is a prompt for Post Attachments lists. I looked through there under validation. There were several attachments, but without knowing the specifics of your question, I was unsure which ones to resurrect.

I would recommend taking the outline provided by Don, and install the more detailed components of your study.

I googled Validation summary report and received a huge amount of hits. There should be some samples there.

Sorry that I can't be of more assistance.

Guys

I am working in Generic Pharmaceutical company and I have been told to write summary report for IQ OQ AND PQ OF THE QUALIFIED WATER SYSTEM I have IQ OQ AND PQ report and data with me but I am looking for any format or example of the summary report I would really appreciate if anybody could provide guideline to generate report

Thanks in advance

:(

If you are working in a Pharmaceutical company, dont you have the SOP for Qualifications and Validations with its associated format ? This is an absolute MUST for Pharma companies. I suggest that you should write the SOP first followed by the actual report for the Water System.

Anyway, apart from the usual SCOPE, PURPOSE, DEFINITIONS etc., ensure that the summary report contains the following -

1. a narrative description of the validation process (or protocol) including acceptance criteria;

2. certification that installation qualification (IQ) and operational qualification (OQ) have been completed;

3. the length of the validation period;

4. the parameters monitored and tests performed;

5. the frequency of monitoring each point of use during the validation period;

6. a validation data summary; and

7. an explanation of all excursions or failures, including deviation reports and results of investigations.

Guys

I would really appreciate your feed back response

abhaygirish :----- Do u send IQ, OQ,PQ & DQ RESULTS I may help you.

I have prepared report and it seems to be great


Thanks

:rolleyes:

I have prepared report and it seems to be great

Thanks

:rolleyes:

Glad to note.