Dear all.
I have recently joined a research laboratory that suppliers biological product to commercial companies. I have been asked to document guidelines to be followed when lab equipments are to be purchased. This document should state the acceptable standards for equipment parts to be used in biopharmaceutical related lab. I want to know where to start and if anyone knows of any requirements that needs to be met by the instrumnent to be used in such labs.
Regards,
sanq
I am also new to validation and hence my answer might be wrong (plz anyone correct me if this is the case). What I think you need to do is write a document called URS where you state what are the requirements for the apparatus. This should also include regulation like GxP and 21 CFR part 11 if applicable. Once you have the URS you need to ask suppliers for a specification of their apparatus. The last stage is then to write a document called DQ where you show each of the URS requirement is met by the product you wish to buy.
Regarding specific standartd for biopharmaceutical such as stainless steel 316 and Ra I cant help you with.
I hope you will find this useful and not more confusing
That is certainly a good starting point, aswell as a Design Spec I would also ask for a Functional Spec detailing how the equipment actually functions
Not far off at all! Lets have a look at what one requires to purchase any Equipment. Firstly the URS-(User Requirement Specification) The name says it all. It is a document in which is described all the relevant features that you want from this equipment, eg, heating capacity, sampling rate, sampling frequency, sample sizes -min and max, consistency, flow rates, etc. It explains what utilities are available at the place where you would like to have it installed eg, volts, UPS power, air pressure for compressed air, enviromental conditions etc. and then any other specification that might be required for that area/equipment.
This is what you would send to your suppliers to quote on and what you would use to measure the system on.
I hope that this has been of some help.