A Personalized Approach To Validation

Tailor-made validation programs are often more successful than cookie-cutter approaches A validation program for a complicated pharmaceutical project can be a daunting task. There are thousands of details to consider, from the day that you begin to lay out the project’s goals, to the day that you complete the project. However, the key to success is very simple: customization. It is impossible to take the same validation master plan and apply it to two different projects. No matter how similar the projects may seem, it is essential to consider all details and shape the plan as precisely as possible. This tailor-made approach must continue throughout the entire project lifecycle. It is also important to customize a program for each client that is consistent with their overall approach, standards, and philosophy, while still maintaining regulatory standards and industry-accepted practices. By personalizing a program and merging it with the client’s approach, the likelihood of consistent compliance can be enhanced. Before you begin Most of the critical work in validation occurs before the project even begins. The first key is to collect all the available information on the project, even things that may seem irrelevant at the time. In validation, the more information you have, the better the chance that you will avoid problems down the road. Before beginning, define what the project goals are, what support is available, and the timeline that you will be working on. You should also identify what work will be contracted out, and what will be accomplished internally. When Day & Zimmermann is hired for a validation project, our most important focus is on maintaining consistent quality throughout all projects. However, we must also reach a balance between the schedule and cost demands of our clients. For example, some clients request our services to assist in the routine qualification activities at a site. In such instances controlling cost while maintaining quality is the primary concern because quarterly budgets must be strictly adhered to. On the other hand, some clients have large, fast-track capital projects and a missed deadline can cost the company a substantial amount of money. In these instances, quality and schedule need to be the primary focus. It is our job as contractors to balance all of the important aspects of a project in order to best meet our client’s needs. The issue of prioritizing is one that is important to consider, whether you are hiring an outside contractor, or performing the validation project internally. Sit down to determine your main concern – is it getting the job done as quickly as possible, or getting the job done with the smallest budget possible? Of course, quality has to be the first consideration, so it is important to be realistic in your planning. You may want a project done in six months, but if bringing it in on time requires cutting corners, you may have to reconsider and adjust your timeline. Once you have a detailed and realistic validation master plan developed, you are ready to choose your team and begin the project. Communicating for success Communication is one of the most important elements to focus on once your validation program is underway. Set a standard for conveying all decisions and data to the entire team, so that relevant information reaches the right people at the right time. Too often, it seems, the various departments involved in a project develop a “silo” approach, where groups are working independently instead of collaboratively, and cross-departmental communication and cooperation suffer. One approach to avoid miscommunication is to meet individually with the various departments, determine their particular “hot buttons,” and devise a middle-ground strategy that can be generally accepted by all parties. Every company has individual project needs and specific processes to handle work instructions. These particular work processes are often different for all projects, so it is important to establish systems to control costs and report the current project status. This helps ensure that all parties and departments have the proper communication channels to review project standings. And it helps avoid any surprises throughout the project lifecycle, and ensures a strong relationship. Establish a simple, trustworthy Corrective Action, Preventive Action process as well. This way, in the event of unexpected issues, the team understands exactly how to resolve and prevent them quickly, efficiently and safely. It is also imperative that the team understands each member’s roles and expectations. To keep things clear, create a detailed matrix of each team member’s defined tasks as a reference point. This helps to avoid gaps or overlaps in responsibilities, so that no critical project element is overlooked or duplicated. Meeting your deadline Validation programs often involve meeting aggressive client milestones. The best way to mitigate this challenge goes back to proactive planning. Anticipating project needs is a key to success, and experience with similar projects can prove to be a great asset. Establish periodic milestones throughout the project, and measure your team against them consistently. Break these down by different sections of the schedule, and evaluate progress and compliance at each marker. Setting expectations is equally important when establishing and following deadlines. Make sure to include all support teams, as well as management, in all communications. Tell them exactly what is needed, by when, and at what values. This keeps everyone fully involved and engaged, and also fosters teamwork. It will also help you realize in advance if you are likely to fall behind schedule, and allow you to make adjustments accordingly. Throughout the life cycle of the project, it is important to establish periodic acceleration sessions. This is an opportunity for members to compress, or accelerate, the schedule where they can to save time and money. You can further motivate your team to cut the timeframe by offering incentives whenever possible. Making cuts to both cost and time help to give you some padding for unexpected delays and other issues. That being said, anticipating challenges does not always work, due to the dynamic and ever changing nature of large capital projects. It is not uncommon to spend a great deal of time and resources to formulate a plan for successful project execution only to have the project scope change drastically. While this is certainly not ideal, it is often unavoidable. In such cases, it is important to remain flexible and to stay sound in your decision making. Often creative solutions can be made that offer a “win/win” solution so that the validation team doesn’t have to start from square one. The important thing is to have a plan to move forward that is agreeable to all parties while keeping in mind that the plan may change. Learn from your successes and mistakes It is essential at the close of a project to conduct a ‘lessons learned’ session to recap the project, reflect on the work done, and gain insight from the experience. This goes back to the value of personalization – once you have been through this process once, you can use the lessons learned to further customize the validation process the next time around. Learn how to avoid the same mistakes, figure out what resulted in successes, and decide what processes fit your company’s needs the best. While every project will be different, sharing takeaways and recommendations will enable you to be better prepared for your next validation project. About the authors: Patrick Polhemus has spent ten years in the pharmaceutical industry, including almost eight years in commissioning and qualification. He is currently a project manager for Day & Zimmermann, and has been involved with projects performing the commissioning and qualification of filling and packaging equipment, utility systems, and automation. Warren Wanlund has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries, including aseptic fill manufacturing, and the development, implementation and supervision of qualification and validation projects for numerous clients.

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