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Employee Appraisals. July 25, 2012 |
PROPER USE OF THE DQ.The Design qualification (DQ) is carried out prior to approval being given to start manufacturing the item to be qualified; if and only if, the item to be qualified has yet to be manufactured from this proposed design.
If the item is off the shelf (already manufactured) then the DQ is used to verify that the design of this manufactured item will deliver all the requirements specified in the User Requirements specification (URS). When the requirement for this item was formalized, a URS would have been raised. This URS would then have been subjected to the execution of a Validation Risk Assessment (VRA). The outcome of this VRA execution produces a documented justification for the scope of validation deemed mandatory and produces a list of all the support documentation that is considered to be essential for this validation exercise to be satisfactorily completed in accordance with current cGMP legislation. So in your procurement file you will have a copy of this detailed list of support documentation, all of which must be considered an essential part of the procurement. If the item is classified; for validation purposes, as high risk, there could be a requirement for documentation that the item manufacturer does not supply I.E. detailed drawings, logic flows, software code, etc. If you decide to purchase anyway, then you are deciding that the company will fund the production of these missing documents. Be aware that this can often exceed the cost of the item being validated. The regulators expect to see that you are using a risk assessment that produces a documented justification for the scope of validation you are applying. They expect to be able to review these documented justifications. The flow of documents from the VMP to the PQ is progressive and comprehensive in the validation world. While the VMP is the showcase detailing how the company has integrated cGMP into all its activities; the VP is the real workhorse. The VP is used to shape and design each validation project. it defines responsibilities, scopes, timelines, access, boundaries testing limits and expectations. Once approved it becomes the controlling authority for the protocol authors. The FDA have stated that over 80% of validation problems originate from faulty procurement strategies. Bottom of Form Climatic Zone Validation Package-1 (Issue 1) This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone. Bottom of Form Climatic Zone Validation Package-2 (Issue 3) This package is complete with all the validation documentation you require to validate the climatic condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP) the Validation Risk Assessment (VRA) the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are 10 highly accurate and easy to use data loggers ready to monitor and record close to 17K (each) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone. Combination IQ/OQ/PQ Protocol.This
combination protocol has been produced in response
to several hundred
reader
suggestions we received in our - Suggestions Section. It has been carefully
designed to make it the preferred choice for Process and Laboratory
stand-alone
equipment. It is an interactive, fully detailed, sixty three page
protocol that
runs to approximately seven thousand words. It is presented in 'MS
Word' to
facilitate ease of final editing by the end user. It has become a very
popular
document.
Combined IQ/OQ/PQ Equipment Protocol (Issue-2). -- $159.00 |