Dear Forum members,
I was posed a question by an interviewer that "Why QA has to approve the SOP or Validation Protocol, BPR and BMR. Why not by Quality control or other functional department.
Can anyone explain?.
I hope huge response…
regards…
R.Dasaratha Rami Reddy.
Hi,
As per my knowledge Quality Assurance is a department which assures that the quality (of product) complies with GMP practices and meets the current requirements based upon the results and outputs of other depts,which inturn has to approve the related quality documents .very, very interesting question…if you ask me. I have an additional question…what does mean to approve an document???..for example…I have wrote SOP about ‘‘how to use Uhlmann UPS 300 blister machine before, during and after production’’… how people from QA can approve this doc if they have never seen this machine in working operation???
rgds,
cubica;)
Cubica,
QA approve in terms of adherence to GxP and Regulatory (FDA, MHRA, etc.) requirements. You as the author are the technical expert and I would suspect that there are at least two levels of approval for your SOP (one confirming the technical aspects and one for the quality aspects). Any system which has quality impact requires Quality sign-off.
In terms of your Uhlmann Blister Former it will have been validated to operate in a certain way, using certain functions/materials/settings etc. and the Validation Report for that piece of kit will have confirmed operating parameters for specific variables. QA ensure that your usage SOP doesn’t contravene those validated operating parameters (e.g. you haven’t said to use type of foil ‘A’ when the machine has been validated using type of foil ‘B’.), and that instructions contained within the SOP don’t contravene basic GMP.
rdasaratharamireddy - Take a look at the Orange Guide sections 1.2 and 1.4 which gives you a basic overview of the roles of QA and QC and how they differ. It sounds as though your interview was probably conducted by a QP who would know this inside out.
Monkey
Dear V.M.
SOP is one thing and WI is other. I am person who is responsible to write SOP about that how to properly and generally use former machine (for example), how to properly start, what is usually check points, how to protect machine, product and yourself, basic principles to setting machine, how to properly change tools, authorisation level…etc…etc) …is there any connection with GMP??? It is only tech. requirements…
WI is something other and has connections (by my opinion, with QA and GMP requirements) …in the sense of the next: which one foil operater will use for Bactimol (type A transparent), for Ranitidin (foil type B ALU light resistant), what will be rpm, what will be cammera settings, how to properly feed tablets, plate’s temperature, how to make IPC, …etc…etc
I am not responsible person for final approving of this WI, I can be only author…that’s ok.
But for SOP??
hmmm…maybe I am not ‘‘at home’’ with all this, but sometime is very strange and funny…we so much talking about signin procedure instead talk about how to protect product, increase safety and reach quality of the same.
rgds,
cubica:)
Hi Cubica,
From the point of view of any decent Quality Dept. the biggest risk introduced to any process is the individual performing a task. Machines can be designed, built, installed, validated etc. to ensure consistent operation but as soon as you introduce humans variation begins to occur. Well written SOPs minimise this risk and that is why it is important to have Quality sign up to it. It may feel as though they are looking over you shoulder and trying to second guess you, e.g. ‘what the hell do they know about setting up the tooling?’, for which the answer is probably ‘not much’, but as a Quality department they have a responsibility to ensure that if you have said ‘go and get tool set A’ in your SOP and tool set A is made of 316 stainless, that 316 stainless is suitable against the current regulatory requirements.
Quality approval shouldn’t be seen as the enemy - if Quality have signed up to something it is they who will be answering the questions come audit time. Essentially they are doing you a favour.
Cheers
Monkey
Dear V.M.
that’s I want to tell ya, QA DO NOT KNOW but the SIGN is important!!! Do you see any problem in this???..you are from QA (very possible)…so you think like that…
is it stupped to sign something if you are not sure or you do not know, or you know like you said ‘’ no much’’ ??? Is it stupped to answer on the questions which you can answer but half or less?? That’s my point of asking…
rgds,
cubica:)
Hi Cubica
You are right, I am from QA - If I approve an SOP I am approving the aspects of the procedure which relate to quality, not the technical aspects (that is up to the technical approver). If your Quality department reject an SOP you have written on technical grounds you should question both their remit and the knowledge of the technical approver (this is why Quality approval should always be last).
On the flip side, if you ask ‘what do they know about the machine’, ask yourself, ‘what do I know about Quality’.
It sounds as though you are talking fairly specifically about something you have experienced - have you asked these questions of your Quality Dept? What was their response?
Regards
Monkey.
Dear all,
I think this question is as old as QA, and I must admit (I´m head of Validations) that QA all too often gets outside its specific duties. In my opinion QA should control (and approve) all the quality related documents from the point of view of their compliance with the regulatory requirements putting in their experience from inspections and audits, and verify the consistency of the documents with other related quality sensitive docs, but regarding the purely technical content their comments should be recommendations but not be mandatory. I´ve had endless discussions with QA about simple wordings in validation protocols (e.g. if the mixing time in a solutions preparation is critical for the efficiency or for the effectiveness of the process) and my feeling is that in many cases QA exert their power conferred by regulatory agencies instead of constructively adding value to the documents.
Best regards
Alfred
Absolutely Alfred, couldn’t agree more.
There is definitely still a culture in some organisations where Quality see their role as judge and jury of just about everything.
A modern, enlightened Quality Unit will recognise their role as being a service in support of a production/manufacturing operation whilst continuing to ensure product/customer safety.
In my opinion, those who get wrapped up in such petty (e.g. wording in protocols) detail are more often than not concealing their lack of understanding of the bigger picture. - With that said though, I do understand the concern over the use of ‘efficiency’ and ‘effectiveness’!
Regards
Monkey
[quote=Alfred]Dear all,
I think this question is as old as QA, and I must admit (I´m head of Validations) that QA all too often gets outside its specific duties. In my opinion QA should control (and approve) all the quality related documents from the point of view of their compliance with the regulatory requirements putting in their experience from inspections and audits, and verify the consistency of the documents with other related quality sensitive docs, but regarding the purely technical content their comments should be recommendations but not be mandatory. I´ve had endless discussions with QA about simple wordings in validation protocols (e.g. if the mixing time in a solutions preparation is critical for the efficiency or for the effectiveness of the process) and my feeling is that in many cases QA exert their power conferred by regulatory agencies instead of constructively adding value to the documents.
Best regards
Alfred[/quote]
…fantastic! Everything is exactly!!! Every word!!! Thanks Alfred!!!
''Absolutely Alfred, couldn’t agree more.
There is definitely still a culture in some organisations where Quality see their role as judge and jury of just about everything.
A modern, enlightened Quality Unit will recognise their role as being a service in support of a production/manufacturing operation whilst continuing to ensure product/customer safety.’’
Great, this is point of our discussion!!! Center of all!!! Thanks V.M. If you working like this you said, than your factory has a great lucky to have you in QA Dept, really!!!
Good, open, honestly and usefull discussion, sharing experiences, thx you both my friends:) it is good to know that somebody thinks on this way.
Look this examples (funny and saddly at same time):
some years ago, I have suggested to make different levels of documentation (till that moment we had only SOPs) …so I’m suggested to have for example SOPs but WI, also. QA people told me that I am not responsible to bring new ideas, to think about that, also. Last year we made WI (on great satisfaction of all Departments), now everything is better, but noboddy told…OK, Cubica was right, this guy has good ideas.
next…QA told that we do not need to have IQ, OQ, PQ protocols:eek: so I’m was against this idea, because, in my opinion, it is not good for us (for example, how we can use external qualification protocol if we do not know how needs to look the same and compare external within our, at least???
)
On my comment like above, they told me like this: what you think you are?? We are main here (judge):mad: shoot your mouth!!!
next…(see this dear Alfred), I had idea to save some money and make an validation team so we can to write some validation protocols ( not only to use external houses), but QA told me that I am not able to do this and approve this documents:
Engineer of electronic, 10 yrs experiences directly from pharma production, trained and certified directly on supplier factory, several years directly worked like operater and Head of maintenance Dept, I have projected several pharma factories which still successful working, author of many protocols which was seen from auditors and approached…CAN NOT sign this kind of docs??? God, kill me, I just can not bellieve…
My dear V.M. all theese mentioned are so far so away from support and service, so far so away from human manners, so far so away from assurance of quality of product (our main duty)!!! My story came from these examples…and, unfortunately there is more… So, as I said, it is lucky factory which has someboddy who think like you!!!
You, Alfred, me and similar to us could be good team for sure.
Thanks, regards,
cubica
Thanks to all , This discussion helped me lot to understand role of QA to approve the documents.
I will be back with new triggers…
R.Dasaratha Rami Reddy
Interesting discussion. I come from R&D. Clashes with QA are endemic. In my humble opinion, R&D is responsible for translating the objectives of Marketing into specifications that Manufacturing can execute against and QA can ensure are properly executed. I would have problems with validations as R&D is often interested in “pushing the envelope” to see how broad specs can be written, while QA is interested in hitting targets, while Manufacturing is looking to not change anything (as it may require changes to contracts, etc.). The best validations then are done with all the key objectives in mind, but QA MUST be responsible for making sure any regulatory requirements are met. Everyone has a job as the “voice of the customer” in that situation. I come from chemical and food manufacturing (not pharma) but the principles of validation are exactly the same (even if the execution is sometimes a little different).
Interesting to learn your views on QA. I am in Qa for last about 20 years and have seen the changing face of it.
First of all we as Qa are custodians and not judges with superpowers. QA does approval to ensure that all the aspect of GXP is taken care while framing the SOP and that the SOP design including format are in line with SOP for SOP. In addition to control changes in these SOP to suit the comfort of users, which may not be acceptable under GMP. This does not mean the user is not quality consious or not educated or not responsible. This is human nature. When we make QA responsible for control & approval, we expect a neutral justified control as they are not directly responsible for prodcutivity and can take decission that is not influenced by this factor. That is the reason why. even reporting of QA is expected to management and not to any one who is responsible for opertions.
I hope you all agree.
WI is something different and have connections in the direction of the other: as a foil to use to exploit Bactimol. If your level of service quality reject a POS that you wrote for technical reasons, you must question both their mandates and understand the technical approval.