Change Control Procedure
Purpose
To
describe the Change Control Procedure for systematic documentation of all changes that is done
in the process, procedures, materials, equipment’s, systems and to review each
change for its impact on process/ procedures &quality/ safety/ identity of
the product due to the change.
Procedure
Preamble:
Change
control system ensures continual improvement is undertaken in a timely and
effective manner. It should provide a high
degree of assurance that there are no unintended consequences of the change.
Definition
Change
Control
It
is a control system for documenting, evaluating, approving and implementing
changes that describes the action taken when a change is done that may affect
product quality or reproducibility of the process. This ensures that sufficient
supporting data are generated to demonstrate that the changes results in a
product or process of the desired quality, consistent with the approved
specifications and regulatory requirements.
Minor
Change
The
change, which are unlikely to have any detectable impact on the formulation,
identity, quality, safety, efficacy, purity and establish system and procedure.
Moderate
Change
The
changes, which are likely to have a significant impact on the formulation,
identity, quality, safety, efficacy, purity and establish system and procedure.
Major
Change
The
changes, which have significant impact on the formulation, identity, quality,
safety, efficacy, purity and establish system and procedure.
Initiation
of Change Control
Originating
department shall send request for the change control to QA.
Executive/Designee-QAD
issue ‘Change Control Form’ with stamping “CONTROLLED COPY Issued by” along
with signature and date in red ink on top right corner on first page of change
control format, second page onwards “CONTROLLED COPY” stamp in red ink on top
right corner on all pages.
Executive/Designee-
QAD assigns an alphanumeric number to change control
If
any separate change control log required to be maintained as per customer
requirement change control numbering shall be done with suffix as first letter
of customer Company name.
The
change proposal shall be logged by Executive/Designee QAD in “Change Control
Logbook “.
Originator
select the change required in, from the options provided in change control form
and provide the brief details of existing and description of proposed change
along with reason / rational / justification for change. Originator shall also
attach documents, in support of justification provided for the proposed change
if necessary.
Head
of Originating department review the change proposal, identify the impacted
system, process and documents due to change proposal, but not limited to, “Guidance
for selection of actions consequent to changes” and shall record the same in
change control Form.
A
project plan shall be prepared by Head of originating department in
consultation with other department heads for changes related to long time
period changes such as modification of facility, procurement of major
equipment/ Instruments and introduction of new software. The project plan
contains the details of project, deliverables, time frame associated with
tasks, responsibility and milestones. The project management plan shall be
prepared “Project Management Plan”.
Handling
of Change Proposal
The
proposals for change initiated shall be handled through ‘Change Control Form’.
The
supporting documents, that provide details of review, approval and
implementation of the proposal, from other departments or Customer and shall be
enclosed to the change control form.
For
handling the change control, follow the procedure described in “Change Control
Flow Chart.
Review
by other Departments
The
QA shall select the other departments and other corporate functions based on
the guidance given in “Matrix for notification of changes to individual
department” and identify the names of the selected functions by indicating with
a tick mark in the applicable box in change control form.
Executive/Designee-
QAD forward the Change control with supporting documents to Head- QA for review
and approval.
Classification
of Change:
Based
on evaluation of the change proposal and review comments the
Executive/Designee-QA shall classify the change as minor, moderate or major (current
version) “Change Control Initiation and Type of Typical Changes” and provide
reason for classification.
Quality
Assurance review and approval of Change Control
QA
shall review the change proposal, impact assessment to change proposal,
supporting documents and classification of change.
After
review Head/Designee-QAD shall finalize action to be taken as per the impact
assessment form.
Based
on the comments from the other departments and as per the impact assessment,
Head/Designee-QAD shall provide the decision on Change Control proposal
“APPROVED/REJECTED” .
On
receipt of approved/rejected Change Control from Head/Designee-QAD, QA person
shall intimate to concerned department.
Current
regulatory requirements shall be considered during assessment of change
proposal (where applicable). If the change requires notification to customer /
relevant regulatory authorities, it shall be notified to them through QA /
Regulatory department and approval shall be obtained before implementation.
Approval
/ Rejection of Change Control by Customer/ Regulatory Agency
Head/Designee-QAD
shall forward the change control proposal for approval or rejection to Customer
or Regulatory Agency (need based mail confirmation can be obtained) e.g. for Filing of variation, notification for
corrective action if any etc.
Need based
scanned copy of actual
change control proposal can be shared with customer
for their reference, if
requested.
On
receipt of change control from Customer or Regulatory Agency, Head/Designee-QAD
shall verify the comments of Customer /Regulatory Agency and approval /
rejection of change control proposal.
On
the basis of the comments by Customer or Regulatory Agency, Head/Designee-QAD
shall forward the same along with documents to concerned department for further
implementation.
In
case of rejection of change control proposal from Customer or Regulatory
Agency, change control shall be considered as rejected even after approval of
QA and same shall be intimated to concerned department by QA.
Implementation
of Change Control Proposal
The
change control initiated shall be implemented by Head of the originating
department under the supervision of Head/Designee-QAD.
After
completion of the identified activities, the status shall be updated by
entering the completion date for each activity in the form “Change Control
Form”.
Originating
department Head along with QA shall be responsible for on time initiation,
implementation and closing of change controls.
After
implementation of any change, an evaluation shall be undertaken to confirm the
quality objectives are achieved and that there is no unintended deleterious
impact on product quality.
An
uncontrolled copy of duly signed first page or the summary page of the
documents shall be enclosed to the change control form to confirm the
completion of activities. List of enclosure shall be documented in the closure
section of the change control.
Post
Implementation of Change Control
After
implementation status verification, Head/Designee-QAD shall decide on, if Post
Implementation impact assessment is required or not required for the change
control proposal.
If
post Implementation impact assessment is not required, Head/Designee-QAD shall
document the decision as not required in change control form and reason for not
requiring the assessment should be documented.
If
the change control requires post implementation impact assessment,
Head/Designee- QAD shall decide on the
number of days and/or number of batches which need to be monitored (as
applicable), after which Post Implementation
impact assessment need to be carried out.
Rationale
for selecting the number of batches and/or time period shall be documented in
the change control form.
The
final closure of change control shall be done after completion of post
implementation impact assessment.
Closure
of Change Control
All
the change proposals shall be approved or rejected within 30 working days from
the date of initiation of the proposed change control.
Once
the Change control is approved, implement the proposed change for minor and
moderate within 90 working days. In case of change control for establishment of
major equipment, instrument, software/hardware systems, facility expansion /
modification, new API vendor etc., change proposal shall be implemented within
one year.
Executive/Designee-QAD
verifies the current implementation status of the proposed change control
during closer verification and identifies the closed and open point of
implementation plan.
Extension
of Change Control (If Not Closed Within timeframe)
However,
if change control is not closed within specified time period, Head of
originating department shall make request as per respective format of
Format/Logbook Issuance Request Form for “Extension of Time Period for Close
out of Change Control”,.
Head
of concerned department shall fill the justification for open implementation
plan, required extension period with requested targeted date of change control
closer and shall forward to Quality Assurance department.
Based
on the Request for “Extension of Time Period for Close out of Change Control”
Executive/Designee-QAD will review the change control.
Extended
period for closing of Change Control is of 30 working days for minor, moderate
and major Change Control. Only three extensions shall be allowed for closing of
Change Control.
In
case, originating department not able to complete the change proposal /
identified activities / review of effectiveness of implemented change control
(if applicable) within the extended target completion date, a CAPA shall be
initiated by following the procedure of “CAPA”.
