I have been assigned to write qualification protocols (OQ and PQ) for a portable Microbial Air Monitoring system which will be used to qualify GMP production zones. There is no URS
Does anyone have examples of such protocols?
- Or, is there anyone who have experience writing these, which could help me out on the points which should be included? Also, is there anyone who has done a risk assesment on such a system?
There must be a whole chain of regulatory required documents in place before you even contemplate PQ.
First there should be a Validation Plan (VP) (it can be quite a simple plan). The plan must give managements reason for using the machine. Along with the use it will be validated for and authority for all required validation methods and actions. It must further delegate responsibilities for all the validation actions, and set the scope of these actions. At this stage a Validation Risk Assessment (VRA) should be used to set this scope. Once these high level decisions are made the VP must be signed off as a working document that has now set the company’s validation requirements for this piece of equipment.
Protocol authors can now write the IQ – OQ – P1Q – P2Q documents, in accordance with the company’s approved practices and procedures. Whether P1Q – P2Q are both required depends on your VP. A machine can have a range of settings and functions, perhaps you only want to validate one process – perhaps you want to validate the entire functionality - perhaps your product is too expensive to waste and you intend to use a placebo to validate the actual process settings. (P1Q - Performance Qualification) (P2Q – Process Qualification)
There are many consultants that would argue, that you must start at User Requirements Specification level (URS), since your P2Q is based on verifying that the URS has been satisfied. This is where the justification for your validation approach must be documented in the VP, without the end user documenting what the equipment is required to do (the exact measurable process and specifications), how can you scope a P2Q?
A P2Q that is carried out using equipment that has not been the subjected to the above procedure (or a very near justified equivalent) has no standing and any product subsequently produces would be considered by the regulators as adultered.
I wouldn't bother. This equipment really only needs to be calibrated for the amount of air volume drawn in, probably 100 liters per minute. If this is wrong then all micro results are suspect.
There may be a few other functions that you are interested in, like electrical power. Assess the risk and keep it lean.
Your company should make the distinction between qualifying production plant and equipment that can be calibrated against a NATA standard etc, balances etc.
But firstly get over the issue of the URS.
Using a URS is just good business sense. I even do one when I buy a new TV. Even better do one when you buy a new car. Its common sense to do a URS for everything. How do you justify to your boss that the new laminator will meet everyones "need".
How do you confirm from the supplier that the item you are interested in is the right one. How do you get your money back when it does not perform, (because you told them what you wanted in a URS before hand, right)
Please do not get a brochure and reel out the specifications as a URS. There is so much you can learn about the process you are looking to buy equipment for by doing a URS. You must draft one up and get input from the end users point of view, the support group point of view and the QA point of view.
Prospective validation starts with a URS. If you buy first and validate second you are in breach of GMP and doing retrospective validation on new equipment, a big no no.