The Installation Validation execution; verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation validation drawings and or specifications. It further details a list of all the cGMP requirements that are applicable to this particular installation qualification. These requirements must all be satisfied before the IQ can be completed and the qualification process is allowed to progress to the execution of the Operational Qualification (OQ).
In the past equipment suppliers have often been delinquent in supplying the right scope and quality of support documentation for their products. As a consequence end user companies have not always had sufficient information (especially in the form of engineering drawings and specifications) about the equipment they have purchased, to develop and put into place the quality of documentation that regulatory requirements demand. For correct and trouble free qualification it is really essential that the scope and quality of the proposed equipment documentation; is specified at the equipment procurement stage.
Our Installation Qualification (IQ) protocol comes with an interactive SOP as an attached prefixed document. As you follow the installation validation protocol requirements as specified in the SOP, you complete the actual IQ protocol. This makes it a really easy and straight forward document to use. The IQ is normally a stand alone document, however, with careful pre-planning, certain aspects of the IQ activities can be integrated with the Factory Acceptance Testing (FAT), and the equipment Commission Testing.
Conformance with continued Good Manufacturing Procedures. (cGMP's) requires, that what ever approach is used, it is fully documented in the individual
Validation (Master) Plan
(VMP or VP).
The IQ should not start with the Factory Acceptance Testing (FAT) or Commissioning tasks, but it should start before these tasks are completed; enabling the validation team to witness and document the final FAT and commissioning testing. The integration of these activities greatly reduces the costly and time consuming replication of unnecessary retesting.
There is a grey area of testing / inspection in the transition from the IQ to the Operational
Qualification (OQ) that is open to rationalization, i.e. it has to be done, but it can satisfactorily be included in either the IQ
or OQ. On most projects the simpler the IQ is
kept, the quicker it is completed,
reviewed and out of the way, allowing progress to the OQ. It can therefore pay dividends to keep the IQ
as basic as possible. Where possible, the IQ can be kept to the pre-powering up stage. Keeping the
this level allows healthy project progress. There should be no
powering up or utility problems to hinder IQ sign off, and rapid progress through the OQ to the Performance
Qualification (P1Q) and where applicable the Process Qualification (P2Q),
becomes feasible. It can be reasoned that as soon as you power up, you enter the equipment operation stage, where verification of the User
Requirements Specification (URS) and 21
CFR Part 11 verification testing are undertaken.
For this reason we have modulized the IQ and OQ, building in the tests and inspections that are not in this grey area, and building the one's that are, as modules that can be added to either the IQ or the OQ. This has not been done just because it might work, this has been advocated by us for some time. We have experience major delays to projects, caused purely by waiting for the client to complete document reviews and approvals. See Comment 9 in cGMP-FDA-483.
The scope of the IQ testing/inspections will cover the under listed subjects, but is not restricted to them alone.
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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. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that 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 documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.
This Validation, 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 very significant difference to the man hours required to produce and execute these documents. 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 costs without infringing regulatory standards.
4Q Equipment Validation 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 validation documentation 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, it is still 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 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.
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 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.