Generating a Validation Plan demands meticulous attention to detail to ensure that a properly balanced schedule of activities is developed. Basic rules and methodologies must be used to determine whether; when there is existing test results for components or systems, it can be used or requires repeating. Bearing in mind; that the aim should always be to preclude unnecessary repetitive calibration and testing.
In accordance with the current regulatory guidelines a risk assessment must be used to ascertain what degree of validation is necessitated by the sophistication, complexity or simplicity of the task. Once this assessment has been approved the plan can be fully detailed and approved. Planning for the validation should include the following elements as well as any other relevant issues that must be addressed to conduct the validation study:
1. Identification of the subject matter to be validated.
2. Criteria for a successful study.
3. Length and duration of the study.
4. Assumptions (shifts, operators, equipment, components.
5. Identification of equipment to be used in the process.
6. Identification of utilities required.
7. Identification of operators required qualifications.
8. Complete description of the process.
9. Conditions to be placed on preceding processes during the validation.
10. Process parameters to be controlled and monitored.
11. Product characteristics to be monitored and methods to be used.
12. Any subjective criteria used to evaluate the product.
13. Definition of what is non-conformance.
14. Statistical methods for data collection and analysis.
15. Consideration of maintenance and repairs.
16. Indications that the process should be revalidated.
17. Stages of the study where design review is required.
18. Approval(s) of the protocol.
The validation plan should also cover the installation and operation qualification of any equipment used in the process, process performance qualification, and product performance qualification.
The validation Plans include a compliant, Corporate Quality Manual (CQM) which is a lengthy fully detailed manual containing all the policies and procedures that the regulatory authorities require approved organizations, to have in place.
The Corporate Validation Manual is the start of all compliant documentation. The policies container in it, dictate what documents must be raised and details the scopes and responsibilities in raising, approving and executing them. Here our CQM goes a great deal further, in containing interactive downloadable templates for, Validation Master Plan - VMP - Design Qualification - DQ - Installation Qualification - IQ - Operational Qualification - OQ - Performance Qualification - PQ - User Requirements Specification - URS - and many more documents, all of which are compliant with Good Manufacturing Procedures GMP, GAMP 5, Food and Drug Authority - FDA, Medicines and Healthcare products Regulatory Agency (MHRA) and all applicable rules and regulations.
Authoring and publishing a Corporate Validation Manual is a long drawn out and expensive process. A single author will usually take six to nine months to produce one. A similar amount of time is required from peers, in reviewing and editing.
Our FDA Compliant, manual preface is constructed in the format of a Standard Operating Procedure - SOP. This SOP takes you through the simple several stages of populating the Corporate Validation Manual. This standard manual template is progressively transformed into your own new company bespoke Corporate Quality manual.
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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 and associated standard operating procedures. The associated Validation Master Plan 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 Online 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.
The Process Validation or Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.
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 standard operating practice 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 Online 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.