I am a little in doubt about the next…
All we here called validation analysts and most of us writing different kinds of protocols…time to time.
I have wrote some protocols meantime (HVAC, cold room, BMS, downflow booth, Laminars, CA…etc…etc) and all of them are approached inspection.
But now, QA in my factory has told me that I am not responsible and qualified person to write an qualification protocol:confused:
I am an engineer of electronic, I am working about 9 yrs in pharmacy OSD plants (from the factory start), I have training certificates for almost all equipment here and, also, I have worked before directly on the machines several years.
So, in my opinion I am qualified enough to see and recognize all important parts of machines, systems…etc to write an good and quality protocol.
Of course, everytime with all respect to EU Ph, cGMP, ISO-xxx.etc…standards and with included education before starting.
Please, will you be so kind and tell me do you or others members here, have some special licences to write protocols, some kind of school, you are approach spec. trainings and where???
Did they give any rationale for their conclusion? Maybe they have instituted new Job Descriptions and you don’t match the defined qualifications for ‘validation analyst’ (or whatever title they established)? Find out what the position requirements are and, if appropriate, discuss with QA how your experience shows you meet the requirements.
Dear Yodon, thx a lot for answer. There is no any reason for this conclusion and there is not logical explanation:eek:. As well as I know, in hole word arround our colleagues write qualification protocols w/o any problem.
I think that noboddy can identify and recognize critical point on systems and structure of the same, than we can, people who working on them and repaire them.
By my opinion, the team generated from factory is apsolutely competent to write protocols and no one inspection on this planet can say that is wrong!!!
I said, just writing protocols…the measurement within calibrated equipment is something other, it works external accredited teams and we use them to verify parameters.
One more thing…on this way we will lose a lot of money, because other teams will do this job instead of us!!! So…we will spend our time here for nothing, do nothing, and my pride goe’s down!!!
I am a little in doubt about the next…
All we here called validation analysts and most of us writing different kinds of protocols…time to time.
I have wrote some protocols meantime (HVAC, cold room, BMS, downflow booth, Laminars, CA…etc…etc) and all of them are approached inspection.
But now, QA in my factory has told me that I am not responsible and qualified person to write an qualification protocol:confused:
I am an engineer of electronic, I am working about 9 yrs in pharmacy OSD plants (from the factory start), I have training certificates for almost all equipment here and, also, I have worked before directly on the machines several years.
So, in my opinion I am qualified enough to see and recognize all important parts of machines, systems…etc to write an good and quality protocol.
Of course, everytime with all respect to EU Ph, cGMP, ISO-xxx.etc…standards and with included education before starting.
Please, will you be so kind and tell me do you or others members here, have some special licences to write protocols, some kind of school, you are approach spec. trainings and where???
Thanks in advance,
cubica :)[/quote]
It’s good to see that an enigneer is willing to write protocols. From a QA perspective it can be seen that it’s a QA responsibility to write the protocols and it’s not about your ability or qualifications. If your QA department will allow you to write these protocols and they review and approve the protocols then I don’t see how it can be a problem. QA is responsible for the requlatory compliance side of things and therefore must approve these protocols.
