| Back to Back Issues Page |
 |
|
Proper use of the DQ. 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-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. 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. Combination
IQ/OQ/PQ
Protocol. Combined IQ-OQ-PQ Computer Protocol (Issue 3) -- $159.00 Software Validation SOP (Issue-2) -- $22.00 Software Validation Master Plan (issue-2) -- $115.00 Software Validation Risk Assessment (Issue 2) -- $125.00 Software User Requirements Specification. (Issue 2) -- $115.00 Software Validation Plan (Issue 2) -- $89.00 Software Design Qualification. (Issue 2) -- $89.00 Software Installation Qualification. (Issue 2) -- $89.00 Software Operational Qualification. (Issue 2) -- $89.00 Software Performance Qualification. (Issue 2) -- $89.00 Software Validation Package (Issue 1) -- $699.00 Validation Risk Assessment (Issue10.) -- $125.00 This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.
Combined IQ / OQ Protocol. With HEPA filters, the manufacturers recommended dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download. Regulators ask to review your writen justification for these filter change PD's; make certain you have them. Free Validation Document Downloads Click Here for further details of CAPA AUDIT document. VALIDATION ON LINE DOCUMENT STORE |
| Back to Back Issues Page |