Procurement procedures must ensure that all designs tendered from Requests for Quotations for equipment destined to be used in the production of a controlled product are subjected to the rigors of Design Qualification analysis. In a similar manner; any “off-the-shelf” items being considered, must be subjected to a similar analysis to verify that their existing design specification is equal to; or better than, the required design specification.
A Design Qualification protocol is used at the stage where a design that has been developed from the, VMP / URS /GAMP 5 / cGMP / and other Health and Safety Guidelines, is reviewed
and documented by competent persons to ensure that the designed equipment, if built, will satisfy all the detailed specified requirements, as contained in the VP and URS.
I have written before in these documents that certain things are critical, well here we are again. You have taken great trouble to write, and have approved, a URS and a
VP, now a vendor (or could be in house) has come forward and presented a design that they have prepared, and they state it will satisfy your requirements. This is where the majority of major project problems are manufactured, not obvious immediately, but materializing later in the project time line.
The Design Qualification is the only document that is going to confirm that the design will work. It must be authored and executed by suitably qualified persons who are knowledgeable enough to challenge the proposed design and its performance. If you have no such persons on your staff you must contract them in, or contract the authoring of the Design Validation protocol out.
When I arrive on site to manage a project, my very first task is always to get to grip with the design, get all the drawings and review them. I do this because thirty years of experience has made me very aware, that I need to know the design is good. So often this is not the case, and very often there are glaring abnormalities. When these are highlighted with the client and their vendors, only the vendors are smiling. The client had accepted the design and the vendor had quoted for that design, any changes will be extra to the quoted price. Sometimes this has run into seven figures.
A PROPER DESIGN QUALIFICATION IS ESSENTIAL TO YOUR HEALTH.
A Design Validation Protocol can also be used where a company has prepared a User Requirements Specification (URS) for a piece of equipment and is searching for a manufacturer, but is offered equipment Of - The - Shelf. A Design validation protocol can be used to verify whether the off-the-shelf item will fully deliver the functionality detailed in the URS, and conform to the requirements specified in the VMP / cGMP while complying with all applicable Health and Safety Notices.
The scope of the Design Validation protocol must include but is not limited to:
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Equipment combined IQ/OQ/PQ Protocol. $159.00
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 and associated standard operating procedures. The associated Validation Master Plan is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that all validation Online executables are catered for and that key aspects of the equipment adhere to approved design intentions and the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the URS.
The Process Validation or Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.
This Validation 4U, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a significant difference to the man hours required to produce and execute these standard operating practice process validation executables. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation 4U costs whilst remaining compliant with their Corporate Validation Manual.
4Q Equipment Validation 4U Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining process validation Online executables documentation and associated standard operating procedures, by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, the Corporate Validation 4U Manual template is written in written in word.