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 nonconformance.
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.
The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
Purchase your copy now at Special Price of $22.00.
The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. 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 ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
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.