Implementing a Change Control Process - Part 2

Posted by Anelis Aurand-Araos

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At WellSpring, as with any other pharmaceutical manufacturing company, we developed a change control policy to ensure that any proposed changes to product or processes were thoroughly examined before they were implemented, and that no unintended consequences would result. As we are currently reviewing and updating our policy, we felt that sharing our methodology would be illustrative of our process and instructive to others who need better processes. 

In our last blog we examined the concept of a systematic approach used in many industries to manage all changes made to a product or process. In Part 2, we’ll look at the distinct steps the system requires in addition to close adherence to a set of quality principles.

Change Request Initiation

Change requests must be submitted only by or via authorized individuals who are trained in the change control process and also trained in the requirements for change request submission and supporting data.

Change requests must include at least the following information:

  • Name of the initiator
  • Description of the change, i.e., current status vs. intended future status
  • Any product, equipment, process or documentation affected by the change
  • Reason for the change
  • Initial evaluation of the costs, benefits and risks associated with change realization

Change Request Evaluation

Evaluators must analyze a comprehensive range of considerations relative to the change, including how it affects all relevant aspects of quality, GxP and business, and they should also consider the risks of the change. In addition, they must assess regulatory impact and ensure that all changes proposed are reviewed so that any additional testing or revalidation undertaken, and any required Health Authority approvals, are obtained before implementation.

Change Control Committee (CCC) Evaluation

The main purpose of a change control committee is to ensure communication between functional groups, collaboration in evaluating a change and strategic coordination for successful change execution.

Change Request Approval

All changes must be approved by the QU before the change is implemented. There must be procedures in place that specify the final approval responsibility for changes with product quality or registration status. Final approval or rejection of change requests must be signed and dated by the approver.


Assuring-Pharmaceutical-Technology-Transfer-Success-eBookThe implementation of the change must be closely tracked by the change owner or change coordinator and, where appropriate, the change must be validated prior to completion of implementation.

  • Implementation of a change on product quality or registration status must be approved by the QA team of the affected sites and may not be performed without approval from local regulatory authorities, when required.
  • Changes not meeting planned timelines or execution task should be escalated to the quality council.
  • Review of the implementation of a change and the closure must be documented in a written summary and/or recorded in the change control system.
  • Where changes to documents require the obsolescence of documents, the obsoleted documents must be removed from the point of use.

A well-ordered change control process:

  • Ensures that the appropriate owners and approvers have been properly identified (including third parties or clients).
  • Ensures appropriate risk assessment has been performed, with mitigating actions added to the change control plan.
  • Ensures that appropriate impacts have been considered and documented (including batch status impact, regulatory impact, validation impact, product quality impact, process design impact, engineering impact and supply chain impact).
  • Maintains visibility of the landscape of changes (e.g., number of open, overdue and un-compliant change requests) and ensures that change requests at the planning stage or beyond appropriate time frames are addressed and appropriate action taken.


Controlling change is important in many industries, but nowhere more so than in contract pharmaceutical development and manufacturing. Even with the best of intentions, all change carries with it the danger of unintended consequences, a negative outcome that wasn’t foreseen in advance. Only by writing and instituting a policy that requires a meticulous examination of each change before it is implemented can WellSpring ensure consistent production of each product throughout its life cycle.

Change is good; change is necessary, but it should always be approached with the utmost care.

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Topics: Change control process, change management, change control committee, QA

Anelis is the Director of Scientific Affairs and Chief Compliance Officer at WellSpring, and has over ten years of pharmaceutical industry experience in Regulatory Affairs, Quality, and Scientific roles. At the University of Florida, Anelis earned her Bachelor of Science in Chemistry, as well as Master of Science in Pharmaceutical Outcomes and Drug Regulatory Affairs. She also earned a Master of Science in Analytical Chemistry at Southern Connecticut State University. In her role at WellSpring Pharmaceutical, Anelis is responsible for the overall corporate quality, compliance, scientific & regulatory affairs direction and strategic guidance for the US and Canadian businesses.

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