By Vonda Ashley

Change management is one of the key elements to a quality system in the pharmaceutical industry. Most pharmaceutical companies understand the need and purpose for change management as an overall concept and have a system(s) already in place to manage changes that include 4 basic steps:

  1. Identify what will be changed.

This can range from new equipment installation, a major issue within the process that is not working and needs to be reworked, procedural updates or creation, or just tweaking a current process for more efficiency and productivity.

  1. Evaluate the impact of the change.

During the evaluation of a change management action, it is critical to identify the full impact of the change since most changes impact more than one area.  It is important to determine all areas impacted and obtain an Impact Assessment from the area representative prior to implementation of the change.  Scheduling an Impact Assessment meeting with all of the impacted area representatives is often times a helpful tool that allows for discussion that can uncover additional impact not originally identified.

  1. Plan and implement change.

Below are examples from a Packaging Production area of things to consider before implementing a change.  A change management plan should ensure that:

  • The benefits of the change outweigh the downtime of line.
  • A clear understanding of what changes are needed, what can be done offline, and what testing will be needed online to verify/qualify the changes.
  • The production schedule will allow the line to be taken out of production during the time it takes to complete the change and test/qualify the changes.
  • Product inventory levels are high enough to last through an unexpected delay should an issue arise.
  • All impacted area representatives are aware of the change, and have the opportunity to offer feedback and assess how the change will impact their area.
  • The full scope of the change is set and does not “creep” into additional changes as the documentation is developed and written.
  • A buffer of time is included in the schedule in the event that unforeseen issues arise that require attention.

The Author of the plan must ensure that:

  • He/she understands the basic process(es) being changed.
  • The plan and associated documentation is clear, concise, and specific for the changes being done in order to maintain the controls around what is changed, but without such detail that the Engineers find themselves in a situation of having to leave a “just found” issue unresolved because it is not within the scope of the change.
  • The plan includes all deliverables required and that the testing strategy and execution is listed completely and fully, following all required policies and procedures.
  • All action items follow the plan, are clear and concise, and are assigned a due date.
  1. Validate and monitor change.

It is crucial that to validate and monitor all changes to ensure accuracy, reliability, consistency of performance, and the ability to detect invalid records throughout the entire product life cycle.

To learn more about successful FDA Change Management, contact a member of our team or click here to learn more about our services.