Implementing a Change Control Process - Part 1

Posted by Anelis Aurand-Araos

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Change control is a systematic approach used in many industries to manage all changes made to a product or process. This is particularly important in the pharmaceutical industry, specifically as it applies to pharmaceutical manufacturing where the complexity of the tasks to be performed during manufacturing, packaging and analytical release testing require detailed documentation of each task. Any changes in how those tasks are performed or managed need to be illustrated and justified through a change control. In Part 1 of a two-part blog, we’ll look at the change control process in general, discuss some of the basic principles and review some of the changes in pharmaceutical development and manufacturing that require following a change control process. In Part 2, we will discuss the steps to implement such a process.

The purpose of a change control process is to ensure that no unnecessary changes are made, that all changes are documented, that services are not unnecessarily disrupted, and that resources are used efficiently. At WellSpring, as part of our continuous improvement initiatives, we are updating our change control policy and felt that sharing our methodology would be illustrative of our process as well as instructive to others who need better processes.



The WellSpring change control process is a risk-based approach that focuses on the importance, impact and complexity of a change throughout a product life cycle. Change control procedures have to be approached as a method of standardizing instructions, and any changes in the production and processes must be controlled, i.e., recorded, reviewed and approved by the quality unit (QU). Certain major manufacturing changes (e.g., changes that alter specifications, a critical product attribute or bioavailability) may require regulatory filings and prior regulatory approval, and local procedures must control for such circumstances.

Responsibility for Change

Key to the structure of the change control process is a universal understanding of responsibility. Management, of course, is responsible for ensuring processes are established and resources are available to support all requirements, whereas the QU has the responsibility of reviewing and approving change requests. Other parties within the change control process are defined in what is known as a RACI diagram, describing parties that are Responsible, Accountable, Consulted, Informed:

Responsible The person who actually carries out the process or task assignment and is responsible to get the job done.
Accountable The person who is ultimately accountable for the process or task being completed appropriately; responsible person is accountable to this person.
Consulted People who are not directly involved with carrying out the task but who may be consulted; these people may be stakeholders or subject matter experts.
Informed Those who receive output from the process or task or who have a need to stay informed.

Training in change management is required for all levels in the organization. Everyone must be aware of what constitutes a regulatory change and how to go about it, in general terms. Owners and reviewers of the specific change control require detailed training about the local SOP and the regulations that govern the process.

Change Requests Requiring Change Control

As an example, changes to any of the following (either initiation of new or changes to existing) must follow the change control process:

  • Product formulation
  • Manufacturing process
  • HVAC systems/air handling systems/air filtration systems
  • Batch/lot size
  • Manufacturing, packaging and analytical equipment
  • Facilities and utilities
  • In-process controls
  • Starting materials: raw materials/excipients/intermediates
  • Primary packaging materials
  • Analytical testing methods
  • Water systems
  • Cleaning and sanitization procedures
  • Suppliers/vendors
  • Production site
  • Stability (shelf life, retest period, storage and transportation conditions)
  • Quality and GMP related documentation
  • Changes in computer systems and software that may have an impact on system validation, product quality or GxP
  • Secondary packaging materials
  • Technical changes related to labeling and artwork (label specification, changes in label materials, etc.)

 Changes to or replacement of equipment or parts with identical or equivalent equipment or parts that do not require validation or qualification do not require change control. However, these changes must be documented, for example, in a logbook.

In an industry such as pharmaceutical manufacturing, where lives can literally hang in the balance, a robust change control policy is absolutely required to ensure that a change in process does not in any way change the quality of the finished product. Only by meticulously documenting every aspect of every change can we demonstrate not only compliance, but quality that goes beyond compliance and thus ensure the trust of our clients.

Next Time: Part 2 — Steps to Implementing a Change Control Process

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Topics: Change control process, change management, Quality Unit (QU), RACI

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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