The Validation Template for the VMP gives an overall depiction of the company facilities, the management structure and details of how cGMP is integrated with all company activities.
The VMP must be an overall document; it should not get bogged down in detail. It must give a clear and concise overview, to a reviewer, of how the company has integrated all the applicable cGMP requirements into every aspect of its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks. All these atributes are incorporated in our Template for VMP.
The User Requirements Specification (URS) is raised by the end user at URS Level One stage, and specifies what the end user requires the equipment to do. Additionally, any regulatory guidance, mandatory instructions or conditions of use, must be included into the URS. The URS must be the subject of one or more peer reviews where the user, the maintainer and QA, review and ensure that the document is clear and concise in all the requirements detailed.
Design Qualification 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 commented on by competent persons to ensure that the designed equipment, if built, will satisfy all the detailed specified requirements. It can also be used to review an of the shelf item to ensure it will satisfy the URS.
The Installation Qualification (IQ) must verify that the equipment has been installed, activated or put into use in accordance with the manufacturer’s requirements, cGMP rules and regulations, and all applicable health and safety requirements. The IQ should further include a review of maintenance procedures, repair parts lists, and calibration methods
The execution of the Operational Qualification (OQ) protocol verifies that the functionality of the equipment conforms with functionality specified in the Functional Specification (FS) for the system. This verification is achieved by subjecting the equipment to a range of fully documented inspections and tests.
It is imperative that all tests and inspections detailed in the validation template for VMP and other protocols are clearly and concisely detailed. Each test and or inspection must be referenced to its effect on the product or the regulation that mandates it. Validation scopes, boundaries and responsibilities must be set out in the Validation Plan (VP). Protocol authors should never be allowed to commence construction of validation template protocols without being made aware of the company constraints, definitions, scopes, and methodology and individual responsibilities as authorized by company policy documentation or the Validation Plan. For concise cost effective document production the authors must be trained in writing protocols in accordance with these comments and incorporating all of the details listed below.
Over-all protocol standards are shown in the SOP’s for the different protocols and are incorporated into template for VMP along with all our other templates. Here we are concerned about the testing element alone. All testing must be detailed and pre-approved by a qualified person to ensure the system under test has been adequately tested. Each test must comprise of;
A Rationale ; giving the reason and or object of the test.
A Test Method ; giving details of the desired test methodology.
An Acceptance Criteria ; giving details of the anticipated acceptable results of the tests.
A Test Result ; giving details of the actual results obtained that satisfied the acceptance criteria.
The test result must be initialled (or signed) by the person executing the tests, on completion or at each significant stage.
Each test must be designed to verify an element of the equipment functionality.
Each test must a have a result that is clear, unambiguous and known.
The test method must call up for the recording of the test result parameters. (No ticks or tick boxes, no generalities).
Each test must be witnessed or the results must be reviewed by a competent person.
The overall test results must be approved by a competent person.
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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