Welcome Message & Introduction to Validation Master Plans

Hello and welcome to my first blog! I must admit that I am fairly new to the whole "blogging" scene but I do hope that this blog, and the subsequent posts that will follow, can be of great use to those individuals and organizations who are my target audience.

I work for a company called Kymanox (KI’-MAH-NOKS’), which means Ideal Knowledge Transfer. Kymanox is dedicated to assisting companies and individuals with knowledge transfer on a project-by-project basis. Our specific area of focus is the Biotechnology, Pharmaceutical, and Medical Device communities.

Working for a company whose focus is Ideal Knowledge Transfer ultimately means that my goal for this blog is to transfer my specific knowledge on pertinent topics in the industry to you, my audience. What specific knowledge do I have, you might ask? Well, over the past year and a half, I have spent a great deal of my time working on numerous validation projects, ranging from equipment validations to computer system and software validations. I have also authored an article for the Journal of Validation Technology on Planning Aspects of Validation Master Plans. Finally, Kymanox offers downloadable templates and training packages specifically on validation at our KymaSTORE, many of which I have contributed to. As you can see, Kymanox, and I, have a great deal of knowledge on the topic of validation.

Introduction to Validation Master Plans

Because Kymanox's focus is the Biotechnology, Pharmaceutical, and Medical Devices communities, validation is a critical component to companies and organizations within those communities. Anyone who is experienced in validation and compliance often mentions that the most important activities associated with validation are strategy and planning. In reviewing FDA observations related to validation, it is noted that there have been multiple observations and citations in which organizations did not adequately address strategy and planning in their validation programs. This is evidenced by FDA's comments on the organizations' Validation Master Plans (VMP).

Interestingly enough, a search of FDA guidance documents finds that only the Center for Devices and Radiological Health (CDRH) guidances on devices and combination products reference the need for VMPs to exist. However, almost no additional detail on VMPs is provided in those guidances. The European Union Guide to GMPs does provide a little more direction on VMPs in Annex 15, Validation and Qualification, by stating the need for validation programs to be documented in a VMP or equivalent document and what topics the VMP should address.

While the VMP is the primary tool for planning validation, it is not a stand-alone document. There is typically a hierarchical structure to VMPs. Figure 1 below shows possible hierarchy options for VMPs.

Figure 1. Possible Hierarchy of VMPs

This hierarchy of VMPs implies that each VMP must have clear scope sections to identify the relationships with other VMPs and explicitly state what is included and excluded. In many instances, VMPs are nested documents, which is illustrated below in Figure 2.

Figure 2. Example Nested Hierarchy of VMPs

The highest level of VMP (e.g., Global VMP) accomplishes the following objectives:

• Defines terms
• References regulatory requirements
• Graphically displays and discusses the validation process steps
• Identifies the requirements to validate various systems
• Identifies the requirements for planning, risk management, qualification, and statistical analysis.

The next level of VMPs (e.g., Site VMPs) describes the procedures to meet the requirements specified in the overall governing VMP. The site VMP can serve as commitment document, policy document, and planning document. The site VMP is specific to each site and includes the following items:

• Description of the site, process, and products
• Systems inventory with the required level of validation for each system
• Timeline, or schedule, for achieving the validation requirements
• Plan for post-validation monitoring and validation lifecycle management

A process-specific VMP includes much greater detail on specific processes than either a global or site VMP. The process-specific VMP helps to define a complete validation system in conjunction with the global and site VMPs.

As you can see, VMPs are much more complex than just a single document. And yet, with little instruction on what they should contain, FDA expects that organizations have VMPs to support the planning and strategy of their validation programs.

Now that I have covered the basics on validation master plans, I feel that I can better explain, in detail, how validation master plans are used to plan validation. My subsequent posts to this blog will cover the three main planning focuses of VMPs in validation, which are:

• The systems inventory
• The validation schedule
• The validation lifecycle management

Please feel free to contact me if you have any feedback or suggestions for this blog. As I stated before, the goal of this blog is transfer my knowledge of validation and validation master plans to you, my audience, so you may find this as a useful resource for daily work applications in your industry.

Best regards,

Megan K Gladfelter