Implementing A Change Control Process - Part 1

7/22/2019 Implementing a Change Control Process - Part 1
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Implementing a Change Control Process -

Part 1
Posted by Anelis Aurand-Araos
Apr 1, 2016 2:35:00 PM
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
www.wellspringcmo.com/blog/implementing-a-change-control-process-part-1 1/7
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.
Overview
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The WellSpring change control process is a risk-based approach
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that focuses on the importance, impact and complexity of a
change throughout a product life cycle. Change control
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procedures have to be approached as a method of standardizing
Resourcesand any changes in the production and processes
instructions,
must be controlled,
About Us i.e., recorded, reviewed and approved by the
quality unit (QU). Certain major manufacturing changes (e.g.,
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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:
The person who actually carries out the process or task assignment and is
Responsible
responsible to get the job done.

The person who is ultimately accountable for the process or task being
Accountable
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.

Made Better Those who receive output from the process or task or who have a need to
Informed
stay informed.
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Training in change management is required for all levels in the organization. Everyone must be
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aware of what constitutes a regulatory change and how to go about it, in general terms. Owners
andAbout Us of the specific change control require detailed training about the local SOP and the
reviewers
regulations
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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.)
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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
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changes must be documented, for example, in a logbook.
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In an industry such as pharmaceutical manufacturing, where lives can literally hang in the balance,
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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
ARE YOU FACING CHALLENGES OF SCALING UP PRODUCTION?

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Topics: Change control process , change management , Quality Unit (QU) , RACI
ABOUT THE AUTHOR
Anelis Aurand-Araos
Find me on:
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
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for the Better
US and Canadian businesses.
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7/22/2019 Implementing a Change Control Process - Part 1

Implementing a Change Control Process -

Responsibility for Change

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

ARE YOU FACING CHALLENGES OF SCALING UP PRODUCTION?

ABOUT THE AUTHOR

SUBSCRIBE TO OUR BLOG

Manufacturing Scale-Up (14)

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