Presentation on-change-control

Definition
Change control is a formal system by which
a qualified representative of appropriate
disciplines review proposed and actual
changes that might affect the validated
status. The intent is to determine the need
for action that would ensure that the
system is maintained in a validated state.

Types of Change control
1 – Minor change is a change that has minimal
potential to have an adverse effect on identity,
strength, quality, purity, or potency of the
product as they may relate to the safety or
effectiveness of the product.
2 – Major change is a change that has a moderate
potential to have an adverse effect on the
identity, strength, quality, purity, or potency of
the product as they may relate to the safety or
3- Critical change is a change that has a substantial
potential to have an adverse effect on the
identity, strength, quality, purity, or potency of a
product as they may relate to the safety or

Levels of approval of
Change control
• “Level -1 signifies level of approval
required to approve a change”
Initiator department and the quality
assurance department only e.g. SOPs
related to single department like
operating procedure of equipment’s,
cleaning procedure of equipments,
etc.

Change control
• “Level -2 signifies level of approval
required to approve a change”
Initiator department and all other
interlinked departments within the
plant e.g. Change in SOPs which are
being followed at different
departments at plant level.

Change control
• “Level -3 signifies level of approval required to
approve a change” Initiator department and all
other relevant departments (within plant or
outside the plant) including marketing, RA and
Quality and Compliance, etc. e.g. Change Controls
which include change in specifications /STPs /
GTPs / Artworks / License related issues / BMR /
process change / Vendor change, etc These type
of changes may require company’s R.A.
department to ask for approval of regulatory
agency(ies) that have impact on regulatory
dossiers submissions.

Procedure of Change Control
Fill the from
Initiator
department, date,
Name & Designation
and proposed
changes along with
proper justification
and assess the need
of training
Head of initiator
department shall
assess the type of
change and changes
required in the
interlinked
documents and
finally countersign
on the proposal.
Any personnel can propose a
change through “CHANGE
CONTROL FORM”
Once the form has been
signed by the initiator’s
department head / designee,
the same shall be forwarded
to QA.
QA personnel shall evaluate
the basic requirements of the
change control and assess
whether change control
requires comments / approval
from Level 1/2/3.
QA personnel allocates a
unique number to the change
control and log the same
number in the “Record of
Change Control”

Procedure of Change Control
After that QA personnel shall
circulate the change control for
approval to different
department Heads or designee.
Comments on the
change control can
be asked from out-
stationed
departments through
email/fax
All the Concern
Department
Heads/Designee shall
evaluate the change
control at their
respective ends and
give their comments
and submit back to
QA for further
action plan.
Head QA or Designee shall
approve or reject the change
controls based on the sound
scientific assessment.
After approval Head QA /
designee, QA personnel shall
send the change intimation to all
concerned department heads /
designee for planning the
implementation of the change
control through electronic means
of communications.
After approval of change control,
QA Personnel shall evaluate the
implementation of same and shall
close the change control only
after all documents or any
activity mentioned in the change
control is closed.

Steps of change control
• Documenting the change request
• Formal assessment of the change
• Proper Planning and timeline
• Final Impact assessment of the
change
• Implementation of change
• Final assessment after
Implementation

• Documenting the change request:
When any change is proposed, the
request form is filled and change is
categorized in minor, major, critical
and recorded, along with informal
assessments of the importance of
that change and the difficulty of
implementing it.
•

• Formal assessment of the change
The justification for the change and
risks and benefits of making/not
making the change are evaluated. If
the change request is accepted, a
change control review team will be
assigned. If the change request is
rejected, that fact is documented
and communicated to the Initiator.

• Proper Planning and timeline
The review team responsible for the
change reviews approval or rejection,
implementation and plans properly for
its implementation within timeline.

• Final Impact assessment of the change
The review team does correct impact
assessment of the change with respect
to GMP. If the change is found to have
no impact on GMP and it is improving for
the system, then the review team
requests approval and gives the timeline
for implementation.

• Implementation of change
The review team also verifies the
implementation status of the change
after approval and the timeline of
the change implementation.

• Final assessment after implementation
If the initiator, review team and QA are
satisfied that the change was
implemented satisfactorily, the change
request is closed.

REMEMBER!
• If a Change Control is pending for
approval for more than 30 working days
from the date of login, it is the
discretion of Head QA or designee to
approve or reject the change control.
• QA personnel shall take the re-
evaluation of the change controls after
every three months or need based.

Presentation on-change-control

Presentation on-change-control

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