Permanent Inspection Readiness for a pharma manufacturing firm

[Quality Girl]

I'm working an a project of permanent inspection readiness for a pharma manufacturing firm. The idea being that we'd be ready to host an inspection should an regulatory agency appear at the door tomorrow. In an ideal world we would always be in this position, but realistically it's not always the case. Has anyone managed a project like this before, and if so how did you approach it?
Clare

[Ajit Basrur]

Originally Posted by Quality Girl

I'm working an a project of permanent inspection readiness for a pharma manufacturing firm. The idea being that we'd be ready to host an inspection should an regulatory agency appear at the door tomorrow. In an ideal world we would always be in this position, but realistically it's not always the case. Has anyone managed a project like this before, and if so how did you approach it?
Clare

Hi Quality Girl,

It can be achieved in reality too

We are audit ready and can face any auditor at any given time. There were a couple of things we did -

1. Daily Housekeeping audit (first impression is the last impression)

2. Once a fortnight detailed IQA by analyst as per checklist. Thus, in a particular month covered most standard requirements and things like CAPAs, Non conforming issues, MRB, Cust Complaints etc.

3. Once a month audit by Supervisor / Manager

All the observations were taken seriously and we could do it.

Not difficult; give a try !!!

[Jim Wynne]

Originally Posted by Quality Girl

I'm working an a project of permanent inspection readiness for a pharma manufacturing firm. The idea being that we'd be ready to host an inspection should an regulatory agency appear at the door tomorrow. In an ideal world we would always be in this position, but realistically it's not always the case. Has anyone managed a project like this before, and if so how did you approach it?
Clare

This might seem like oversimplification, but you can make a list of the things that keep you from being audit-ready and then devise a plan to address them. This is more important than it might seem because the fact that you state that you're not ready for audit means that you're not in compliance with the requirements or expectations. The goal should be a system that's in compliance at all times.

[Sidney Vianna]

I don't know if it would apply in the UK, but in the US, many retired FDA Inspectors work as consultants to assist organizations being ready for scheduled and unscheduled audits. You might consider something along those lines.

But I agree with the feedback you have been given so far. Your mind set should be one that it is possible to be in compliance with the requirements, in a cost effective manner, at all times. If your organization has a defeatist approach in terms of compliance with requirements, you will always be doing window dressing in preparation for an audit.

[BradM]

Originally Posted by Quality Girl

I'm working an a project of permanent inspection readiness for a pharma manufacturing firm. The idea being that we'd be ready to host an inspection should an regulatory agency appear at the door tomorrow. In an ideal world we would always be in this position, but realistically it's not always the case. Has anyone managed a project like this before, and if so how did you approach it?
Clare

Hello, quality girl!

Sorry, but my radar went way up on this one, and I may be reading too much into this. What regulatory agency(ies) would be entering your facility? Have you not mustered audits from these before?

I would think you should already have tried and true procedures. If you do, you are either compliant to those or not.

Are you conducting internal audits? How have they been going? Are all the observations been dealt with?

I may be envisioning a 'monster that don't need to be slain'. But there are a plethora of issues ranging from validation of equipment, sterility, storage, records retention, calibration, etc. I would think all of this needs to be addressed at some point.

[Quality Girl]

I think I gave the wrong impression. We have been audited by a number of agencies including the MHRA, FDA, ANVISA among others. We have never done badly in these inspections but what always seems to happen is a general air of panic in the run-up to an audit. I want to rule that out, and as you say internal audits and mock inspections are probable the best tool for that.

[Al Rosen]

Originally Posted by Quality Girl

I think I gave the wrong impression. We have been audited by a number of agencies including the MHRA, FDA, ANVISA among others. We have never done badly in these inspections but what always seems to happen is a general air of panic in the run-up to an audit. I want to rule that out, and as you say internal audits and mock inspections are probable the best tool for that.

It doesn't matter how ready you are, it seems panic always ensues.

[BradM]

Thank you for the follow-up. Now I can rest better

In my opinion, Al hit it on the head. This panic always seems to manifest itself. In my opinion, here are a few reasons:

1. Incompetent managers-getting mad at people when a process has been found to be deficient. Someone is to blame, and they are gonna find them! They do not deal well at all with auditors and their purpose.

2. Incompetent auditors- they are auditing out of their scope, they are not trained properly, not professional, don't write up the process/ standard, asking leading/cornering/ defensive questions, etc.

3. Audit training- along with internal audits, I have seen many times mock audits, and training on dealing with an auditor. Basically, how to keep all off of the defensive (as much as possible), being objective, not pointing fingers, etc.

4. Every audit I have ever been associated with, something is always noted. That's just the way it is. They will most probably note something in your audit. Hopefully, it's just a minor thing.

Some of this you cannot fix, some of it you may be able to deal with. In the end, the managers of the area can help you the most by making sure prior issues have been dealt with, and by dealing appropriately with audit findings.