| You might be wondering what master validation plan | | | | documents that will be needed. The key elements |
| is and how to create one for your organization. This | | | | are those factors that can have an effect on |
| article can help you understanding the principle of | | | | product quality. |
| master validation plan and what is involved in creating | | | | The content of the MVP should reflect the |
| one. | | | | complexity of the extent of the validation activities |
| If you are in pharmaceutical business you have | | | | to be undertaken. At minimum the MVP should |
| already noticed that you need a validation plan for | | | | address the following: |
| qualifying your equipments, processes, cleaning | | | | 1. Title, statement of commitment and approval page. |
| systems, buildings and facilities. It is a regulatory | | | | 2. Summary description of the project and its scope. |
| requirement for you to create one and implement in | | | | 3. A statement of validation policy and the objectives |
| your site. If you are to make your product safe, | | | | of the validation activity |
| pure, effective and identifiable at all times for human | | | | 4. References to other existing validation documents. |
| use, you definitely need to create an effective MVP. | | | | 5. A description of the organization and responsibilities |
| An effort to define master validation plan (MVP): | | | | for validation |
| MVP is a strategic document which identifies the | | | | 6. The validation strategy to be adopted opposite |
| elements to be validated, the approach to be taken | | | | Facilities and Systems (process equipment and |
| for validation of each element, the organizational | | | | services including automated systems), Materials, |
| responsibilities and the documentation to be produced | | | | Quality Control, Personnel including training. |
| in order to ensure full consideration is given to | | | | 7. The intent in respect of Process Validation and |
| product quality aspects. It will show how the | | | | Cleaning Validation for each of the drug product |
| separate validation activities are organized and | | | | range. |
| inter-linked. Overall it provides the details and relative | | | | 8. The documentation management and control |
| timescales for the validation work to be performed. | | | | system to be used. |
| You have to create standard operating procedures | | | | 9. A description of the validation change management |
| for the preparation of validation documents which are | | | | process. |
| approved by the Quality Assurance. | | | | 10. An indicative relative timescale plan. |
| When does a MVP required: | | | | 11. Clear acceptance criteria against which the |
| A MVP is needed when significant changes are made | | | | outcome of the validation exercise will be judged. |
| to the facilities, the equipment and processes which | | | | Reporting requirement for master validation plan: |
| may affect the quality of the product. A risk | | | | Each MVP should result in a report confirming that all |
| assessment approach should be used to determine | | | | validation activities have been completed |
| the scope and extent of validation. The MVP should | | | | satisfactorily. |
| be available prior to starting any of the validation | | | | It is recommended that a Summary Validation Report |
| activities | | | | (or Master Validation Report) is prepared which |
| What should a MVP contains? | | | | summarizes activities undertaken, presents the overall |
| Each MVP shall describe the scope of the activities | | | | conclusions and provides cross references to any |
| and address relevant key elements of validation | | | | associated reports or follow up actions. |
| affected by the change, indicating the actions and | | | | |