How to Create a Master Validation Plan

You might be wondering what master validation planEach master validation plan shall describe the scope
is and how to create one for your organization. Thisof the activities and address relevant key elements
article can help you understanding the principle ofof validation affected by the change, indicating the
master validation plan and what is involved in creatingactions and documents that will be needed. The key
one.elements are those factors that can have an effect
If you are in pharmaceutical business you haveon product quality.
already noticed that you need a master validation The content of the MVP should reflect the
plan for qualifying your equipments, processes,complexity of the extent of the validation activities
cleaning systems, buildings and facilities. It is ato be undertaken. At minimum the MVP should
regulatory requirement for you to create one masteraddress the following:
validation plan and implement in your site. If you are1. Title, statement of commitment and approval page.
to make your product safe, pure, effective and2. Summary description of the project and its scope.
identifiable at all times for human use, you definitely3. A statement of validation policy and the objectives
need to create an effective master validation plan. of the validation activity
 An effort to define master validation plan (MVP):4. A description of the organization and responsibilities
MVP is a strategic document which identifies thefor validation
elements to be validated, the approach to be taken5. The intent in respect of Process Validation and
for validation of each element, the organizationalCleaning Validation for each of the drug product
responsibilities and the documentation to be producedrange.
in order to ensure full consideration is given to6. The documentation management and control
product quality aspects. It will show how thesystem to be used.
separate validation activities are organized and7. A description of the validation change management
inter-linked. Overall it provides the details and relativeprocess.
timescales for the validation work to be performed.8. An indicative relative timescale plan.
 You have to create standard operating procedures9. Clear acceptance criteria against which the
for the preparation of validation documents which areoutcome of the validation exercise will be judged.
approved by the Quality Assurance. 
 When does a MVP required: Reporting requirement for MVP:
A MVP is needed when significant changes are madeEach MVP should result in a report confirming that all
to the facilities, the equipment and processes whichvalidation activities have been completed
may affect the quality of the product. A risksatisfactorily. 
assessment approach should be used to determineIt is recommended that a Summary Validation Report
the scope and extent of validation. The master(or Master Validation Report) is prepared which
validation plan should be available prior to starting anysummarizes activities undertaken, presents the overall
of the validation activitiesconclusions and provides cross references to any
 What should a MVP contains?associated reports or follow up actions.