Validation, a requirement of the FDA, is an all-encompassing program that ensures your manufacturing facility’s equipment and processes function properly, meet regulatory requirements, and consistently produce a high-quality product.
While the entirety of a validation program is a complex series of tests, processes, and documentation, you can break it down to into three simple steps:
This simple overview provides a useful framework for how you should think about and approach your validation program.
The Validation Master Plan (VMP) is a document that fulfills that first step, then guides steps two and three. It serves as a guide for what validation processes will be undertaken at your facility and how you’ll execute those processes. It also establishes a plan for documentation to ensure regulatory compliance.
Without an effective VMP, you’re making it harder for yourself to meet project deadlines, execute a successful commissioning and qualification process, and ensure regulatory compliance.
Here are a few ways a well-written VMP can impact your project.
1. Ensures a high-quality product
In Pharmaceutical manufacturing, as in any type of manufacturing, the goal is to produce a quality product that best serves the customer’s needs.
The Validation Master Plan outlines a process that ensures that everything works as intended and that your facility will consistently produce a quality product. An effective VMP successfully identifies what needs to be validated, how validation should be achieved, and the impact of the various equipment and processes on the product’s quality.
2. Helps avoid regulatory issues
The FDA issues numerous 483s and warning letters every year, often because of poorly written VMPs. Your VMP needs to be well-written and thorough to avoid unforeseen regulatory issues.
By providing a definition of terms, a validation strategy, a list of roles and responsibilities, a scope of validation, an explanation of your approach to validation, and other vital information, your VMP is your safeguard against running into any significant problems with compliance.
3. Reduces friction and miscommunication
Having one master document minimizes friction and miscommunication between stakeholders, project managers, upper management, project team members, and other personnel.
As the authoritative source for the project’s validation strategy, the VMP gives everybody access to the information needed to understand and assess the manufacturing processes and their impact on product quality.
4. Guides project scheduling and budget management
As a centralized reference point, the VMP can provide vital insight to help project managers overcome challenges, including risk management, scope management, budget planning, and timeline management.
It’s especially useful for project managers to anticipate any needed resources and the scheduling of project timelines.
To complete your project on time and within budget, it’s critical to have an effective VMP.
Manufacturing facilities face countless challenges throughout the project lifecycle. An effective and thorough VMP is vital to the project’s success, especially as it relates to product quality, regulatory compliance, and budget and timeline management.
As a centralized and authoritative point of reference, your VMP can help anticipate obstacles and develop a strategy to overcome them. A good VMP offers extreme value to engineering, quality assurance, upper management, project managers, and most importantly, the customer, who receives a high-quality product that improves their life.