I started a new job about 8 months ago. We are contract manufacturers producing complimentary medicinces only.
When I started I was handed a mess, there were qualification documents missing for almost every piece of equipment, in a company that has over 180 manufacturing staff. The company had a history of producing documents and misplacing either the electronic version, or the hard copy, sometimes both. For example in the last TGA (Australian version of the FDA) audit, the VMP could not be located. Anyway, that’s why they got rid of the last guy and hired me. Somehow we kept our licence to manufacture.
I have now requalified every piece of equipment in the place, instituted a file system where any document for any piece of equipment can be located in minutes or better. So that is all good. Big job, glad it’s done.
However, The Validation documents for all the proceses were found in one place and appear to be current. There are no change control records to suggest anything has been changed in each process, but then, there are no change control documents for anything else either. I’d like to be able to argue in the next audit that all processes remain validated, but this sounds a bit too much like being a little too economical with the truth.
Should I just bite the bullet and revaildate all our processes, or do I have a leg to stand on by arguing that they remain valid? I have a healthy dose of self-interest here, once this project is complete I’m promised a good pay rise and a great promotion.
First of all congrats on getting your validation back on track, I think many of us in the validation world understand what you have gone through.
The problem you now face is maintaining the control you have created and ensuring everything stays in a state of compliance with your validation. The problem you really face is the huge amount of documents you have created and the paper that goes along with that.
What I would suggest is the option of going paperless, we now use a new solution called Kneat Validation to perform all of our validation activities securely and online in a collaborative manner.
Kneat allows us to manage all of our requirements, test online, manage deviations, manage change controls, manage all of our templates in a consistent manner and review/approve everything online.
I don’t want too sound too sales pitchy but this level of control cannot be achieved by using MS Word. Their website is
Good Job on bringing your company up to speed. I’m in the very same boat myself. Here we have implemented in our VMP that we will periodically assess our processes. When was the process validation performed? Depending on the age of the validation you may have a very simple assessment ahead of you. However, if your company did not keep change control documentation, and an agency realizes that, they will immediate challenge any old documentation. I would suggest at minimum an assessment of the process. If there have been no changes to the process, and no adverse trends, that should suffice. In addition, most companies I have worked for operated under the assumption that at minimum, 1 passing run should be obtained for cleaning validation 1-3 years following initial validation. This 1-3 year timeframe was determined using a risk assessment. Where is the equipment in the process, what does it see, ect. I hope this helps.
I was thinking along similar lines. I’m going to update the VMP to say each process will be assesed periodically, and as we only manufacture complimentary medicinces, we have a bit more lattitude than a company manufacturing API’s. The validations for all our processes are less than three years old, so an assesment should suffice as all the equipment was requalified without any problems coming up, and we haven’t had any significant quality issues for the past few years.
When I started this job it took me 6 weeks of sorting through piles of random documents before I realised how enourmous the job before me was. I even had second thoughts about whether I wanted to job. But doesn’t it feel great when you have everything sorted out, everything in place? We have a TGA audit in three weeks and eveybody else in QA is feeling pretty stressed. Me? I’m looking forward to it. I know there will be a few things that they’ll want me to change, but on the whole I’m feeling confident. At least this time we’ll be able to show them the VMP!
To anyone else in the same position as I found myself, just keep chipping away, get a little more done each day, and eventually you’ll get it finished. It helps if you can organise your project in a ghannt chart, turn one big project into a lot of small tasks and it makes it easy to keep track of things, and you can see your progress.
Hello Paul,
I do work in the same industry ( Dietary supplements/Complementary medicines) and the company I work for (in the U.S) is regulated by TGA as well (we manufacture products for Australian distribution). When I developed our VMP, I added a section where I explain that equipment assessments are conducted periodically (1-3 years -after qualification/validation) and if no irregularities were found (per documented assessment), the equipment/process remains under control and in a Qualified/Validated state. We were Audited by TGA last year and the auditor was happy with the documented assessments. My assessments/and report are brief and to the point. Let me know if you need additional information.
Omar
I don’t suppose you’d be able to forward me an example of one of your assesments could you? I’d certainly apperciate it. Brief and to the point sounds like exactly what I’m after.
[quote=odominguez1]Hello Paul,
I do work in the same industry ( Dietary supplements/Complementary medicines) and the company I work for (in the U.S) is regulated by TGA as well (we manufacture products for Australian distribution). When I developed our VMP, I added a section where I explain that equipment assessments are conducted periodically (1-3 years -after qualification/validation) and if no irregularities were found (per documented assessment), the equipment/process remains under control and in a Qualified/Validated state. We were Audited by TGA last year and the auditor was happy with the documented assessments. My assessments/and report are brief and to the point. Let me know if you need additional information.
Omar[/quote]
Dear Omar and Paul:
My experience goes back in same situation.
My suggestion for this would be to create a matrix for validation of equipment and keep only critical parameters to verify based on the risk analysis during revalidation.
The frequency for the re-validation is different for different equipment. Decide the time lines for revalidations and frequency in the matrix.
Follow the schedule and keep it updated.
Moreover Statistical analysis is also gaining importance in Validations, Prepare a trend of critical parameters and with statistical analysis calculate Cpi & Cpk values and demonstrate that the equipment works fine and your process is in control.