VALIDATION TEMPLATES FOR VMP AND ASSOCIATED PROTOCOLS.
The Validation Master
Plan (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.
Template for DQ
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
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
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.
Validation Templates Documentation Interface.
It is imperative that all tests and inspections detailed in 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 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
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
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
Sub-headings in Test Scripts.
A Rationale ; giving the reason and or
object of the test.
; giving details of the desired test
; giving details of the anticipated acceptable results of the
; giving details of the actual results obtained that satisfied the
details that must be adhered to.
The test result must be initialled (or
signed) by the person executing the tests, on completion or at each significant
test must be designed to verify an element of the equipment functionality.
test must a have a result that is clear, unambiguous and known.
test method must call up for the recording of the test result parameters. (No
ticks or tick boxes, no generalities).
test must be witnessed or the results must be reviewed by a competent person.
overall test results must be approved by a competent person.