Operation Validation Definition.
"Execution of the Operation Qualification protocol must produce sufficient data to verify that; all the operation functionalities mandated in the User Requirements Specification, have been fully complied with."
This Operation Validation must be verified with the execution of a Operation Qualification (OQ) protocol. This is a really easy and straight forward document to use. In the preparation of the Operational Qualification validation protocols, it is important to allow a degree of flexibility. This must and should be specified in the
Validation Plan (VP). Should the OQ remain untouchable until the Installation-Qualification (IQ) is completed
and signed off? There are many instances where this is not just undesirable but senseless and deleterious to project progress
and costs. Should every function in a system or piece of equipment be qualified? It makes little sense to fail something for not reaching a parameter that you are not going to use. The Operation Validation must include a review of the Standard Operating Procedure (SOP's) for start-up, operation, maintenance, safety, and cleaning / sanitization as applicable, must they be in fully approved format? These flexibilities must be built into the qualification process. However there is an abundance of rules and guidelines that are not flexible, and must be rigorously adhered to. The modular process has been followed in constructing this Qualification, in as much that where tests / inspections are standard for systems and or equipment, they are built into the basic protocol. Where they are not they are available as test protocols. Functional and software tests are authored in this stand alone test scrip protocol format. When the OQ is being raised they are pasted in. The document format will paginate them, and automatically add them to the ‘Table of Contents’. They are
then part of the OQ. These Test Scripts can be held as Method Statements or SOP's. This allows the generation of a standard OQ that covers all the many
items the regulators are looking for, with the facility to have integrated into it, the equipment specific testing tasks. It also means that these stand alone test scripts are available for tasks other than validation, i.e. when system re-testing is required.
It also saves unnecessary testing and re-testing. For example, when a room pressure regime has been commissioned by another party and the completed report is in date and available, is it practical and legal to use it? There is no reason why not, providing it has been authored, and executed using the same documentation practices and procedures as are used in the routine production and execution of validation protocols. The OQ test scrip will be of standard format, the contractors tests (containing the raw data) will be reviewed and data extracted from it. This data will be used to verify that the Operation Validation test script acceptance criteria has or has not Operation Qualification Rationale.been satisfied. The raw data from the contractor now forms part of the OQ, and must be appended to it permanently, along with copy calibration certificates for all the test equipment used in obtaining the raw data.
Where you use your own indigenous testing methods contained in an SOP or a Method Statement (or whatever you decide to call them), they must be used in a manner similar to the manner the contractors raw data was used.
The scope of the OQ testing/inspections must include but is not limited to:
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SOP for Spreadsheet Creation. -- $125.00
does something as simple as a spreadsheet figure in so many regulatory
citations? Good question; and at times a difficult one to answer. When
you ask a group of compliance personnel the same question you will be
informed that Excel cannot be validated because it does not seal the
original copy (of the spreadsheet), allows the original to be modified
and has an audit trail that can be disabled. All true, but none of
these problems interfere with your ability to validate that the
spreadsheet is fit for purpose. They only preclude you from using the
spread sheet as a compliant repository for any data that has to be store
in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hard copy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.
Equipment combined 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 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.
The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable cGMP requirements as specified in 21 CFR Part 11, 210, 211 and 820 into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks. It must mandate the production of all Practices and Procedure manuals and SOP's.
The VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes. It is a master reference for all validation variables and queries.
When you declare that your validation is Risk based; then it is incumbent on you to use a suitable tool to convert the perceived level of risk to an appropriate intensity of validation. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities. This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance rulings.
During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task. The use and scope of the individual documents has been documented, discussed and explained in detail. It is therefore obviously best policy to have in place exactly what the regulator is looking for. The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated