Validation Policy Template Sample

Validation Policy Template

The Process Flow

Validation Master Plan – Your company policy on Validation approach

User Requirements Specification – Specify your needs

Validation Plan – Document your Validation Method and specific plan here

FAT – Factory Acceptance Testing (Test all requirements at supplier site

Installation Qualification (IQ) Document your installation requirements

Operational Qualification (OQ) Document all Operational/Functionality Checks

Performance Qualification (PQ) Document Performance consistency

Summary Report Summarise all your validation findings

What is Validation?

Validation is to license equipment, a system or process to function against a predetermined outcome which has been established through prior studies of materials, product or the process itself. The Validation procedure begins as a project and then becomes a living state until the equipment, process or system is decommissioned or is no longer required.

Validation is a legal requirement under the European and US law governed by regulatory bodies – MHRA for the European market and the FDA for the US market.

Validations began heavily in the pharmaceutical industry and were later adopted by the Medical Device industry under legal requirements from the FDA and MHRA. It is now becoming a practise in the Automotive and Electronics industry.

Your Standard Operating Procedures – SOPs As part of your manufacturing procedure you must have Standard Operating Procedures to ensure that all stages of the process of manufacture is standardised under a controlled document that is easy to follow which can be assisted with aid of visual diagrams or photos. The SOP must also be written in the language that is understood and be clear and unambiguous. The SOP must follow Good Documentation Practise.

Your Master Validation Schedule – controlling your programme Your Validations need to be outlined in a clear timeline with dates for completion with responsibilities.

This must be a living document with dates for revalidation once the original validation has been completed. The revalidation frequency can be determined on risk and criticality of process. A frequency of yearly or every two years is common. At the intervals the equipment/process/system will typically be review for any change or any issues raised during the interval, and an assessment will be made if any revalidation activity needs to take place or if this can be justified with a rationale.

Your Validation approach – Validation Master Plan/Policy Your site wide document and take on validations should be clearly outlined in a high level document which is your Validation Master Plan or Policy which indicates your approach to validation from software systems to lab, cleaning, equipment etc. Responsibilities and your revalidation programme should also be listed here. A statistical programme must also be clearly outlined here.

What are you ordering/validating – writing a User Requirements Specification

Very often people will purchase something and then consider validation. This is in fact contrary to a robust validation programme, since the Validation programme must begin prior to purchase. The User Requirement Specification outlines what is required, without this document the supplier may supply you equipment that has not been clearly understood. On some occasions an email detailing requirements with specifications or an uncontrolled document may be sent to the supplier, however without having this reviewed, approved and signed by all responsible parties causes confusion and disagreement at some point of installation and commissioning. To prevent mishaps and out of good practise it is advised to have a URS in place, which became more of a requirement in the pharmaceutical industry. In the URS you should also document how you wish the delivery to take place of your supplied equipment.

Your supplier response – Functional Design Specification (FDS or similar) In response to the URS the supplier should detail a Functional Design Specification detailing how the equipment they will supply you will achieve your requested specifications. If this is not supplied you will also be at risk of accepting equipment that has not clearly been understood by the machine manufacturer/ supplier.

Testing what you have ordered before it is shipped – FAT Once the supplier has documented and described how they will achieve your specifications and you have agreed that the project can progress you must monitor the progress using a project plan. Regular visits should be agreed to monitor progress and ensure that all activities are correctly being pursued.

Any complications must be understood, mitigated and dealt with as part of project planning. The FAT is a Factory Acceptance Test document. Once the machine has been completed a test script must be provided to the supplier which is the FAT document. The tests will take place and witnessed by you and the supplier. The FAT is a controlled document detailing all the tests that took place, and signed off. The FAT document must be completed to satisfaction to provide you with confidence that the machine is ready for shipment to your site for installation and further qualification.

Installing your equipment – Installation Qualification Once the equipment has been despatched you must have all your plans for installation ready in order to accept the equipment, locate it and begin installation. The Installation Qualification (IQ) document is the start of the Qualification process, which is a controlled and approved document. Your IQ protocol must be approved with all the necessary checks with field entries for execution to check against the equipment at the time of installation. The protocol will be written using manuals and details of the equipment from the supplier. This is agreed and approved and executed with engineering knowledge.

Checking the limits - Operational Qualification Once the equipment is satisfactorily installed, and the IQ protocol is executed with all tests being satisfied against acceptance criteria, the IQ must be signed off by the same approvers who approved

the protocol prior to execution. Upon successful IQ the equipment is ready for Operational Qualification (OQ). The OQ checks for all operational/functional checks of the equipment. The OQ is also a controlled protocol reviewed and approved under similar procedures as the IQ. The OQ document must be prepared and ready for execution immediately.

During the OQ, you must then establish the range of parameters, which may be advised parameters which were tested at the FAT or some other study. If there is no basis to begin the parameters a full Design of Experiments must be put in place to ensure a full array has been explored. All permutations must be trialled with product to test. The most befitting parameters must be used to establish a range.

This study must be captured as part of the OQ. The range must then be used to run product under a statistically sound sampling plan. (It is advisable to consult someone who understands sampling plans or a six sigma qualified expert at this stage). Once you have performed all functional checks and established a range, you must provide evidence of running product through the established range and test the products to success. This will demonstrate that the equipment will perform successfully within a “boundary� of parameters, and after these parameters are breached the equipment should alarm and stop. Once these checks and tests have been satisfied and documented, the qualification can progress to PQ.

Performing consistency – Performance Qualification Upon successful OQ, the equipment is now ready for PQ to demonstrate consistency, reliability and repeatability of performance. The PQ protocol, similar to the IQ and OQ must also be a signed and approved protocol to allow execution to take place after OQ. The PQ is typically performed with three consecutive batches. There is no hard and fast rule to use three, but this has commonly been used throughout the Medical Device and Pharmaceutical industry to demonstrate consistency. Consecutive batches must be used to ensure there has been no break where the first batch passes, second fails.

Therefore this requires requalification. The principle being that PQ must not fail if OQ has been performed correctly. There should be no failure at PQ for the validation unless it is for something other than the subject of validation. Any failures must be clearly documented and deviations documented where necessary. If the failure is due t the subject of validation the deviation must be written and tests repeated from the first batch. Once successful data is achieved and documented the PQ protocol test scripts must be well documented and completed. All tests must be clearly signed and witnessed by a second person. Upon completion of PQ the qualification phase can be deemed complete.

Summarising your reports Upon completion of all qualification, summarise all your findings in a summary report with conclusive evidence. This summary should be documented and archived with the rest of the Validation.

Upon this stage the equipment will be handed over to production.

Reference your document here

Written By:

Other references

Revision: 01

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VALIDATION POLICY Your Logo

Document Title: (further description here)

Page 1 of XX

1. Purpose The purpose of this policy is to give an overview of Validation activities as applied at the (Your plant name here). This policy will outline key steps that must be taken and general requirements expected to be met for all Validation activities. This policy is written as a high level document interpreting FDA and ISO guidelines and is the basis of the company roadmap to Validation. The policy is written in line with FDA 21 CFR QSR part 820 as follows: “Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled” The testing performed during Validation activities provides sufficient evidence to ensure that objectives are met with consistency.

2. Scope This document outlines the approach to be taken for validation of GMP critical processes at the (name your plant here). This includes, but is not limited to, Manufacturing Facilities, Utilities, Equipment, Processes and Analytical Methods, as well as Computer Systems that forms an integral part of the above systems.

3. Related Documents Document all your related documents here that ill be required for Validation – URS, VP, DQ, FAT, IQ,OQ, PQ etc.

4. Definitions and Validation Policy (in brief) Document your approach to all of the following 4.1

Analytical Test Method and Laboratory Equipment Validation:

4.2

Calibration:

4.4

CCR: Change Control Record

4.5

Cleaning Validation:

4.6 4.7

Combined Qualification: Computer Systems Validation (CSV): Black Box Testing: “In cases where software code is not investigated the testing will be based on challenging predetermined inputs and outputs”.

White Box Testing: “Where source code is available to interrogate CSV testing will involve challenging code”.