The wisest choice that can be made, is always to buy-in a professionally prepared suite of validation documents along with the validation executables. The format and content used in Professional documents are usually copies of used documents that have been, used and re-edited several times. Which means they have been in front of the regulators before and used satisfactorily. The dread of finding; late in the project execution, some aspect of the system that has not been catered for; or even, things that can't be catered for at all, is just too horrific to contemplate: But not unknown. So we author and register the following documents:
Conventional: VP - URS - VRA - DQ - IQ - OQ - PQ
Since these documents sequentially cascade from the VP through URS, VRA, DQ, IQ, OQ, PQ and finish with the P2Q (when both a performance and a process validation are required). This progression is of the utmost importance since the documents are inter-referenced and are required to be executed sequentially. This is why it is important that the documents are designed and written as a package; where, the correct cross document sequential and chronological requirements can be authored in.
Advanced: VrrP 4Q
In the new Validation risk & requirements Plan (VrrP) document, the contents of the original VP, VRA & URS have been brought together and edited into a more user-friendly format. The new format is much easier to work with and simpler to collate and edit. This document now compliments our equally new 4Q Protocol, which has evolved from the editing and collation of the old format DQ/IQ/OQ/PQ documents; without the cGMP integrity of each individual protocol being compromised. This is an essential step forward for companies seeking to reduce validation costs without infringing regulatory standards.
Numerous validation inquiries led us into collating various validation executables to form validation executables suites containing all the required protocols; along with the supporting documents, such as the VP and the VRA. This simplifies the user selection task. The packages have been arranged for three levels of validation executables for process, production, facility and utility equipment and separate bespoke packages for Software, HVAC, Networks and other stand-alone systems.
The complete chain of regulatory required documentation required to enable satisfactory for the validation executables of a computer / DCS / PLC / ERP, system. This Validation executables Package contains one of each of these documents VP - URS - DQ - VRA - IQ - OQ - PQ.
You want to validate a relatively minor, new or replacement piece of equipment that is going to be used within a facility that is fully validated and subject to change control.
In this case you require :- IQ, OQ, PQ.
You want to validate a process line that has been subjected to major modification, but is validated and is continuing to use the same processes to produce the same product.
In this case you require: VP, URS, IQ, OQ, PQ.
You have a new facility and you want to validate it. In this case you require:-
VMP, The global master plan for the whole facility.
cVMP, The master plan for all computer systems. VP, which will define validation executables boundaries, methodologies and responsibilities.
URS, DQ, VRA, IQ, OQ, PQ. For each piece of equipment.
For Your Security We are Now TLS 1.2 Compliant
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. It 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 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.
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 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 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.
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s and standard operating procedures, are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained along with compliance with your Corporate process Validation Executables Manual requirements.
The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process validation that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it sometimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste and all relevant standard operating procedures are approved.