VMPs As Commitment Documents

One of the many services we provide at Kymanox is commissioning and validation of many different types of systems, from equipment to software. Kymanox not only executes commissioning and validation of systems, but we also create all of the documents to support validation. One of the documents that is usually created to support validation is the Validation Master Plan.

In the pharmaceutical, biotechnology, and medical device industries, it is paramount that the products manufactured are done so under strict guidance and supervision. Quality systems are put into place to ensure the safety and efficacy of the product; while validation ensures that systems, equipment and processes are reproducible and reliable. The Validation Master Plan (VMP) is the primary document that houses all aspects of the validation process and conveys managements overall intent, including defined validation scopes, scheduling of required work and responsible persons.

A VMP is more than a plan for executing validation. It is a commitment from the organization to ensure that the validated systems satisfy regulatory expectations. There various sections in a VMP contain different commitments from the organization. While the VMP is used to plan validation and outline the commitments from the organization, it is also a forward-looking document that must include a commitment for maintaining the validated state of systems in the future, as well as achieving a validated state for systems in the near-term.

COMMITMENTS IN A VMP

The VMP is viewed by regulatory agencies and auditors as a commitment document and is frequently one of the first documents requested in audits. A VMP is an overall commitment to ensure that systems, equipment and processes are validated and in compliance with governmental regulations. It demonstrates that the products manufactured from those systems and processes meet safety and efficacy requirements for the end customer. The subsequent posts to this blog will discuss the following specific commitments made in a VMP:

• A commitment from the management of the organization
• A commitment to how compliance is achieved
• A commitment to properly planning all aspects of validation
  

Any comments or questions are welcomed.

Best regards,

Justin Pawlik

Introduction Post

Welcome to my new blog about working as an Operations Executive in the Pharmaceutical, Bio, and Medical Device industries. Specifically I will be discussing articles written by my staff and me for various technical journals. The reasons for writing and publishing the articles are two-fold; Kymanox has an opportunity to educate the masses by writing about what we do on a daily basis; and we are able to promote Kymanox by having our company name published in well-respected technical journals.





I have been working at Kymanox for approximately two years. Coming from a very large pharmaceutical organization, I truly enjoy and cherish the dynamics of a smaller company. Kymanox is very nimble and can react to the changing times much faster than larger more bureaucratic companies. For this reason, Kymanox is not just surviving during these difficult economic times but actually thriving!

Kymanox (ki’-mah-noks’) is derived from Greek and means Ideal Knowledge Transfer™. The company was founded in 2004. Kymanox focuses on providing Ideal Knowledge Transfer (IKT) to help organizations achieve predictable project success. We provide comprehensive services on all of our projects to ensure the satisfactory completion of all scoped worked while remaining within all budgetary, schedule, and quality constraints. Since Kymanox is able to provide solutions to companies on a per-project-basis, we remain lean and efficient.

Kymanox is interested in creating long-term value for its clients. All work preformed is done on a project basis and each project starts with a value proposition analysis. It is this analysis that determines what value Kymanox can and will provide. In today’s business environment, it is sometimes difficult to identify all the customers and stakeholders for a given project or product. Keeping this in mind, Kymanox takes special care in handling multi-party projects. Scoped deliverables remain on-time and on-budget while keeping overall customer satisfaction high. Lastly, Kymanox emphasizes communication and transparency to its own operations so that decision makers and contributors are empowered with accurate and timely information.

In contrast to the traditional consulting model, Kymanox offers its clients a full-range of services related to Technical Project Management, Engineering, Process Operations, Quality & Regulatory Compliance, Commissioning & Validation, and Automation & Software with staffing that matches only what the project requires. Utilizing our experiences and talents, we have also developed various templates and training packages to assist other companies in providing Ideal Knowledge Transfer to their employees.

If you are looking for best-in-class services, please contact Kymanox.

Over the following weeks and months, I will update this blog with information that might be useful to those in this industry. Comments and suggestions are welcomed.

Best regards,

Justin Pawlik