How to write a superb Validation Plan

How to write a superb Validation Plan - introduction.

How to write a superb Validation Plan or generating a Validation Plan Template 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  validation plan template 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 Plan template study:

1.     Identification of the subject matter to be validated.

2.     Criteria for a successful Validation Plan template 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 template should also cover the installation and operation qualification of any equipment used in the process, process performance qualification, and product performance qualification.

Validation Manual Plans

The validation Plan template 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 plan 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 plan 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 Plan Manual. This standard manual template is progressively transformed into your own new company bespoke Corporate Quality manual.

Authoring Templates into Quality Protocols.

It is imperative that all tests and inspections detailed in the validation plan template for VMP and other protocols are clearly and concisely detailed.  Each test and or inspection must be justified by quoting the requirement that mandates it.  Validation scopes, boundaries and responsibilities must be set out in the Validation Plan template (VP).  Protocol authors should never be allowed to commence construction of validation template protocols without being made aware of the company constraints, definitions, scopes, methodology and individual responsibilities as authorized by the company practice and procedure policies  as promulgated by the company.  For precise effective validation plan template tests and inspections must be cross-referenced to the requirements detailed in the User Requirements specification, which mandates their inclusion.

Over-all protocol standards are detailed 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 must be justified and verified as fit for purpose comprise of;

Main Sub-headings in Test Scripts.

Rationale; giving the reason and or object of the test.

Test Method; giving details of the desired test methodology.

Acceptance Criteria; giving details of the anticipated acceptable results of the tests.

Test Result; giving details of the actual results obtained that satisfied the acceptance criteria.

In producing a "How to write a superb Validation Plan" compliant plan these general details must be adhered to.

The test result must be initialed (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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User Requirements Specification Template

The User Requirements Specification template is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected for cGMP use that all essential support elements; i.e. maintenance, parts, operator & maintenance training, are planned and budgeted for.  It uses three levels of User Requirements Specification Template (URS), URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final OQ and PQ functionality testing. A requirement mandated by cGMP regulations. It can be used on mechanical, electrical and software controlled, monitored or driven systems. 

Corporate Validation Manual $1,160.00

This definitive 1000 + page (including all attachments) Corporate Validation Manual arrives with you in USB memory stick format, this enables you at any time to download protocol or test-scrips documents and quickly edit them into company bespoke documents. In fact there are over $3,500.00 worth of superb documents, that form attachments to the DVM manual, which can be instantly copied. Once copied, the unique document interactive editing, allows you to produce high quality bespoke company documents; Such as the Validation Plan Template or the equally ubiquitous User requirements Specification template Design Qualification (DQ); in a few hours. The cost of the Definitive Validation Manual, will be recouped in the first few weeks of use. It will then go on to show a massive return on your original investment.