ROFE Meeting 16 February 2024

CHANGE
CONTROL In
Regions and
Administrative
Areas
February 22nd, 2008
 Change Control training 22 Feb 2008 Slide no 2

SCOPE

• This instruction solely covers minor

changes
• Minor changes are changes that
have no registration impacts.
• Minor changes can be divided into 3
sub-categories (M1, M2 and M3)
depending on the business impact,
including whether the change
concerns several sites/areas or might
affect validation status.
For a description of this, please see
the relevant instruction (cf. the table
in section 2)
 Change Control training 22 Feb 2008 Slide no 3

What is it about?

• It is about controlling the changes

we perform on:
• product-related equipment and
facilities, e.g. storage facilities,
product stores, transport,
distribution and archives
• local critical computer systems
(without registration
consequences)
• critical processes incl. related
documentation. E.g.
discontinuation of products,
organisational changes having
impact on the QMS.
• contracts for GMP-critical processes
 Change Control training 22 Feb 2008 Slide no 4

This instruction does not apply to:

• changes to computer systems

with registration consequences,
key documents in Data
Management, registration
documents – see also Doc.
110989 Change Control in
Production Areas

• printed packaging materials and

advertising materials are not
covered by this instruction - see
relevant RA operational
documents.
 Change Control training 22 Feb 2008 Slide no 5

Why Control Changes?

• In order to have the process approved via relevant parties in

line of business, QA and, if applicable, by authorities prior to
implementation of the change
• To Correct identify the change and its scope, including
product and process impacts
• To have a rationale, risk and cost/benefit assessment of the
change
• Involving all relevant parties in the process (incl. RA and QA)
• Planned relevant training of affected parties/employees
• Timely implementation of approved changes
• Learning from the follow-up process on implementation and
the results of the approved changes.
• To have a Consistent and adequate documentation of
changes
 Change Control training 22 Feb 2008 Slide no 6

Change Control Process

• 4 Phases:

Preparation Decision Implementation Reporting

 Change Control training 22 Feb 2008 Slide no 7

Responsibilities
• Affected dept.
• Evaluate the consequences of a given change for own area
and accept or reject the change
Applicant
• Prepare a complete change request
• Is responsible for driving the change control process in
accordance with this instruction
• Set to work on or take the necessary steps to identify,
reasons, test, validate and implement the change
• QA
• Assure correct classification of the change requests
• Evaluate whether the consequences of the change are
adequately described and documented
• Approve or reject a change based on compliance and quality
issues
• Monitor the implementation and make the final conclusion