Master Validation Plan – GxP
Background
Our client is a small biotechnology company with a pipeline of products in advanced clinical development stage. The product portfolio they intend to offer into commercialization is across multiple therapy areas. It is a very science-driven company with majority of the senior management team from background in sciences, medicine, and manufacturing.
The Challenge
The company was on a digital transformation drive to support an upcoming commercialization. 2 of their key products were on registration paths at different regulated markets. With the advent of technology in many areas across the GxP domain, they were building activities of validation and control around the new technology that was introduced. There seemed to be a challenge to understand how to handle this from a strategic perspective.
The key objectives they were looking for were:
- Align all technology compliance to the US and EU requirements
- Ensure GxP compliance
- Prepare for upcoming inspection
The solution:
RiverArk consultant experts provided an overall perspective of how to achieve this. The model to build a Validation Master Plan to support was proposed. Active discussions with the senior leadership team within the organization were held. The Validation team was identified and set up with clearly identified goals and responsibilities. The following aspects were covered in the setup of Validation Master Plan.
- Systems, equipment, methods, facilities, etc.,
- Current validation status for the systems within the project scope
- Compliance requirements for validation, including how the validated state will be maintained
- Schedule of validation activities
- Required validation deliverables
- Validation documentation format
- Current validation procedures and policies
- General validation risk mitigation strategy
The result
The VMP was created and is now a unifying document which helps to create a common understanding of the company’s approach towards validation in all team members to enable effective organizing and execution of validation activities. It also serves to help management understand what the validation program involves and why it is important.