The Second Planning Focus of VMPs: The Validation Schedule

Hello again and welcome back to my blog on validation at Kymanox! As my first post explained, Validation Master Plans are the primary tool for planning validation in the industry that Kymanox services, and there are three main planning focuses of VMPs. My last two posts discussed the systems inventory and determining the appropriate level of validation for each system. This post will focus on the second planning focus of VMPs, which is planning the validation schedule.

The VMP outlines a plan which includes the validation schedule. The validation schedule is one of the most important components of a properly written VMP. The schedule contains the activities that are going to be performed during the official validation, as well as the pre-validation activities and non-validation activities that need to be performed. There are many specific techniques that should be used when developing the schedule in a VMP. The following techniques will help to ensure that validation runs smoothly and the overall schedule can be maintained:

• Where possible, use task dependencies instead of hard dates. Equipment and laboratory methods used in a process must be validated before the process validation is performed. Cleaning validation should occur after process validation. Using dependencies as the basis for the schedule is crucial. Scheduling specific activities to be completed by specific dates (i.e. 01MAR09) will usually result in a VMP that is behind schedule by the time it is first approved. The validation schedule is a commitment, and using dependencies instead of hard dates will assist with preserving the overall schedule.
• Schedule specific time for non-validation and pre-validation activities. Validation protocols take a significant amount of time to draft, revise, and approve. Also, engineering runs, calibrations, and commissioning should be performed before beginning any official validation activities. Validation is the confirmation of a system’s operation. Therefore, validation should not be the first time the system is operated and tested. Neglecting these activities can result in unnecessary deviations during validation that could have been easily avoided.
• Include time and resources for contingencies. At least one non-conformance, deviation or variation will likely occur during validation. Resolving a non-conformance takes time and effort, which needs to be included in the validation schedule. Also, equipment may break down or the availability of raw materials could be delayed. All of these unforeseen events will require additional time. This contingency time should be built into the validation schedule from the start and clearly specified as contingency time.
• Include any up-coming company holidays, planned shutdowns, and preventative maintenance (PM) activities in the overall schedule. Quite often, projects consist of multi-company efforts and multicultural team members. Being aware of all relevant holidays will help to prevent unforeseen delays due to lack of available resources for the project. Also, planning for shutdowns and PM activities will ensure the overall schedule can be achieved.
• Schedule time for any required training that personnel executing the validation may need. Having trained validation technicians will help to ensure that all validation activities are valid. Training takes time and resources, so include it in the schedule. Also, including training in the VMP schedule will assist with demonstrating to inspectors the organization’s attitude toward the quality of validation.
• Ensure that the equipment and systems to be validated will be available for validation. If any in-use production equipment is required for validation, be sure to inform production of the validation schedule. Additional time should be included in the schedule to allow for delays in procuring the equipment from production. It may difficult to take production equipment out of service, even if production is aware of the requirements ahead of time. By keeping production “in the loop” regarding the equipment needs, the validation schedule can be maintained by preventing delays in procuring equipment.
• Maximize data collection during validation activities. One production run can sometimes be used to collect data for the equipment PQ, process validation, and cleaning validation. Collecting data for several different validation activities at the same time will minimize the required overall validation time. It can also create extra time for unforeseen delays that may delay the schedule.

The validation schedule is the primary planning tool in the VMP. The schedule is also a commitment, and changes to the schedule may raise red flags for inspectors. Incorporating these specific techniques into the validation schedule will assist with ensuring the validity of all validation activities, demonstrating to inspectors the organization’s commitment to the validation quality system, and maintaining the overall validation schedule.

My next posts will discuss the final planning focus of the VMP, which is planning validation lifecycle management and post-validation monitoring. Please feel free to contact me with any questions or comments you have regarding this blog. Thanks!

Best regards,

Megan K Gladfelter