SOP for GMP Audit API

Hello ,

Please help me to how GMP Audit for API manufacturing and written SOP specify the scope and frequency of audits…with the check list…

Thank you all,



Hate to say this but sounds like you aren’t qualified to do an audit (thus not in compliance with the expectation that personnel are qualified to perform tasks assigned).

If you’re under the gun and can’t get training needed, you may want to consider getting a consultant for the short term.

I presume you’re needing to conduct an internal audit. That would be done to confirm that operations are complying with how you said they should. Scope would be everything. Frequency is yours to define; however, expectations are that you cover everything within a year (i.e., you can audit chunks at a time but over the course of a year audit everything).

I know that’s not much help but auditing is a discipline that can’t be imparted in a response such as this. Failing to use qualified individuals is not added value to anyone.


I am not agree with you , I am trying to write a SOP for Auditing for both internal and Vendor 's aduiting , I have enough information and also have check list for that , just plan to get more ideas for this .

Ok, no offense intended at all.

It’s just difficult to respond to such an open-ended question in a forum like this. More focused questions often get more responses.

Hi Jack,

Do not take our statements offensive.We are all great friends. I shall give you some important tips how to frame a SOP check list during the SOP development.

  • Look at Dispensing Techniques
    -Look at the utilities and readings and how frequently they are recorded.
    -Look the frequency of change over of products and measures taken.
    -Look at the quality control aspects and release of starting materials.
    -Look at the cleaning aspects.
    -Review the Environment and Health and safety.
    -Review your CAPA procedures.
    -Review your BMR.
    -Review your SOPs and Training methodologies.
    -Review your hierarchy. This based on experience-Traing first and qualifications next. Not in the reverse order.
    -Metodologies to track Change controls.
    -How good is ur validation team and Validation documents.
    -How good is your product storage and Release.
    -How robust is your packing and Stability programme.
    -How robust is your risk assessment.
    -How compliant is your batch archieval process.
    -How linear are your HPLC method validation procedures.
    -How well you clean your premises.
    -How do you do technology transfer
    -How can you implement QMS/QSIT programme for continual improvement.
    -How robust are your IT systems.


Well, at the risk of endangering friendship, let me respond. :slight_smile:

An auditor’s function is strictly to assess compliance to defined procedures. “Looking at dispensing techniques” is not in an auditor’s scope. If the procedures define a particular dispensing technique then the auditor can assess compliance to that technique.

An auditor should not assess robustness although if there are indications that quality could be affected by a lock of robustness, an auditor may note an observation.

An auditor, by NO means, should assess ‘goodness’ of the validation team. Performance of individuals is completely out of scope. An auditor should only focus on the process. Even if the auditor observes an individual doing something that is a non-compliance, the finding should be a process non-compliance, not tied to the individual. It is up to the team, not the auditor to determine what the root cause is and enact positive changes to avoid future NCs.

Don’t get me wrong, many of the things noted are quite important to ensuring overall quality but should not be up to the auditor to assess.

Hi Yodon,

Its great to see your comments.

I had a hard time once with auditor regarding dispensing techniques and trainings involved in that. We were forced to take his comments positively and improve overall situation.

Again, looking back into the question, I do not have any idea regarding the level of expertise Jack has. But at the same time I should be honest in letting him know the situation I faced.

-Validation Team : This might be assed by an Internal auditor or an agency who can be hired by company to carry out external audits like the Pre-Inspection audits. This might and can happen.

I would love to see your insight regarding the new comments I posted.


As with any function, there are good auditors and bad auditors. Some come in with the attitude of process improvement and this is just flat wrong. They are there to assess whether you follow your procedures or not. Period.

Did you ask what requirement the auditor was citing when he was commenting on your dispensing techniques?

Training is another matter. Per just about any standard, employees are expected to be competent to perform the tasks they are assigned. Most companies rely on training to show compliance to this. So if the company procedures said that anyone operating the dispensing equipment (or performing V&V) required training, the auditor is fully within his rights / scope to ask to see training records. Even if the procedures don’t mention training, the auditor may ask how the company ensures that any particular individual is qualified to perform the tasks assigned.

You specifically mentioned “how good is your validation team.” That’s quite different from whether or not they are qualified. They are qualified through training and experience. They can still do a poor job but from an auditor’s perspective, those are 2 separate aspects.

If an auditor raises an issue, it should always be framed around a process requirement. If they can’t relate a finding to a process requirement, it’s quite likely they’ve crossed the line into trying to drive processes rather than assess compliance.

Hope that clarifies. Always happy to discuss.

Hi all,

I really appreciate all you guys, I got good points from your discussion and better idea regarding the GMP Audit .

Thanking you ,

Yes, we were asked show how we dispense.
The whole pandora box opened as one of our guys did not calibrate or not properly calibrated the weighing balance. It opened a discussion into SOPs that are present, how we read and follow etc etc.

Regarding Validation team: One of our so called group leaders ignored worst case validation on an Ultrafiltration water system in one of our parenteral plant. It has to be tested based on the reading obtained from Volumetric flow meters. The effects on reduction of pressures both inlet and outlets of valves of the UF unit must be conducted and should be documented. We ignored worst case study. The external auditor raised this point and also looked into the team and descision making.

Ofcourse these issues saved the plant ultimately.

Now that you explain it, I think your auditor was probably in line.

It sounds like he didn’t challenge the method you used for dispensing but asked to see how the process was operated. Which led to seeing that a balance was used which led to the calibration question… And those things certainly are within an auditor’s scope.

And on the validation issue, that (worst case study) is just good validation practice so that’s also fair game. And since protocols are supposed to be reviewed by those approving, it certainly begs the question of the effectiveness of the review.

Ok, I think your auditor was probably on track with his work.

I’ve heard too many cases where auditors wanted companies to do things their way (and the more unscrupulous ones even tried to offer their services to get them “compliant”).

Good discussion; hopefully it helped others understand what the scope of an auditor is and how the auditor should always tie things back to the process.