SOP on Change control

 PROCEDURE:

 TYPES OF CHANGE CONTROL:

 DOCUMENT CHANGE CONTROL (DC) :

 Initiation of a document or modification of approved

documents including but not limited to Master Batch Records
(MFR/ BMR/ BPR), standard Operating specifications, Method of
Analysis, format / Labels, Qualification / Validation Protocols,
Stability Protocol, Validation Master Plan, Policies and
Guidelines, Site Master File, Change in manufacturing process
 FACILITY / ENGINEERING CHANGE CONTROL (FC):

 Planned modification, Major maintenance, removal /

decommissioning and inclusion of equipments, utility, facility /
building.
 INITIATION OF THE CHANGE CONTROL:
 The Department, by whom the change / modification is
initiated, shall first request for change control form from QA and
fill up the change control form with brief details of the change and
the reason for the same with proper justification.
 Quality Assurance shall issue a change control form &
allocate a change control number according to the nature of
 change requested.  the numbering system described in this SOP
and shall note the number in the change control log.
 APROVAL OF PROPOSED CHANGE & IMPACT
ANALYSIS:
 The initiator shall then complete the change control form
in all respect elaborating the scope / justification of the change in
consultation with concern other department(s) as appropriate the
details of these documentation have been describe in the
documentation approach  of this SOP.
 The existing system and the proposed change shall be
briefed in the specified sections of the change control (separate
sheets can be used, if necessary).
 The initiator shall also perform the impact analysis in
co-ordination with other concern Department(s) and write the
recommendation if any as specified in the section of change
control form.
 The Manager of the initiator department should review
the change control form and the impact analysis and add any
recommendation for a limited number of months based on prior
approval of QA. The implementations of preceding years shall also
be reviewed in the current APQR.
 The department Manager is to sign of the change control
form and forward it to Quality Assurance for review.
 Quality Assurance should recommend/ any additional
actions if necessary and identify the requirement for comments of
other affected department with consultation of Manager Change
 control then shall forward to other affected department for their
comments (Whenever required).
 If required comments of any department which is
available outside the plant including Corporate Quality (CQA),
change control shall be forwarded to respective department
through scan copy / hard copy / any other communication mode.
Signed scan copy should be attached with change control (where
required).
 Change control shall be forward to plant Manager for
his / her review and comments.
 QA shall take the comments of customer / contract giver
on respective column of change control form (Whenever required)
through scan copy / hard copy / any other communication mode.
Signed scan copy should be attached with change control
(Whenever required).
  QA  shall review the completion status of initiation,
impact analysis, comments of other responsible personnel and will
sign as reviewed by the change control form and completely filled
change control shall forward to Manager – QA / Designee for
Approval / Rejection of change control.
 When the change control is raised for new product /
process / equipment impacts on the cleaning validation, process
validation and analytical method validation shall be analyzed
specifically along with the impact on other Manager ings.
  The Manager -QA / designee shall review the impact
analysis and approve / Reject the change control with addition /
deletion of recommendations as appropriate.
 The Manager -QA / designee shall tick on the Category
(Critical, Major & minor) and Approved / Rejected status.
  QA  write NA wherever Not Applicable after approval
of change control.
 The Manager -QA / designee shall assess the change(s)
and assign the category as follows:
Category “X” – All Minor Changes which are not classified as major.

# Change in non – critical equipment, which will not affect the quality of finished
product.

# Any other change that will not affect the registration material and the Quality
of     finished product.

Category “Y” – All major changes having effect on the following

#  Registration material (registration application, including supplements etc.

#  Manufacturing process affecting the quality of finished product.

# Control methods and limits used as the basis for release, which is not affecting
the quality of the product.

# Product specification, which has been submitted to the authorities.

# Changes in stability specification.

# Changes in the shelf life of finished product.

# Changes in document, which will affect the registration material.

# Change in solvent used for drug product manufacturing

Category “Z” – All Critical Changes are likely to have an impact on the critical
process, procedure, product or system and document. These changes are evaluated
against the current commitments and requirement which is directly affect the
quality of the product.

 All the recommendations shall be endorsed by the impacted department

Manager s and shall be responsible for compliance of the recommendations.

 The change control form should be submitted to quality Assurance

Department within 7 working days from the issue of the change control
number, otherwise the change control issuance shall be cancelled and the
change control number shall be invalid.

 IMPLEMENTATION / EXECUTION OF THE CHANGE:

 The date of implementation of the change / initiation of modification
shall be assigned by Quality Assurance after receipt of the compliance
reports of the recommendations that are to be complied before the
implementation / execution.
  All the recommendation that are to be complied before the
implementation of the change / initiation of modification shall be
complied before the implementation /execution initiation date.
 The change shall be implemented from the implementation date
mentioned on the Change control form.
 All the recommendations of the change control shall be taken care of
during and after change / modification. The initiator department and the
impacted departments shall be responsible for the implementation /
execution of the change and compliance of all the recommendations.
 Manager Quality Assurance will review the Risk Analysis as
appropriate.
 After compliance of all the recommendations, Quality Assurance
department will review the closure of the change control and get the
closure approved from the Manager Quality Assurance.
 CHANGE CONTROL NUMBERING SYSTEM: The change control
number should have the 12 digit following details:
 The change control number consists of following characters format as
described below.
 (——-) (–)         (——–)             (–)        (——–)         
(–)         (        )
Dept. Code   Slash Type of   Change Slash   Sequential No. Slash Year of
Change.

The first sections (Two characters) are alphabets and are the department codes.

The third character is Dash “– ”

The second sections (4th & 5th characters) are alphabets which indicate the type
of change e.g. DC for document change request,

FCR for facility / engineering / area change request,

SCR for system related change request.

Next Sixth character is slash “– ”

Next section (7th, 8th & 9th characters) are numeric indicating the change control
number in the current calendar year, which will start from 001 for each functional
department.

Next tenth character is slash “– ”

Last two (11th & 12th characters) are numeric representing the last two digits of
the current calendar year.

e.g.: QA-DC-001-18 indicates the First change control for Document

Change given in year 2018 for Quality assurance dept.

 GENERAL DOCUMENTATION APPROACH OF CHANGE

CONTROL:

 Change control form shall have the change control number dully
allotted by QA and received by initiator department, which is responsible
for the movement of change control document for subsequent approval.
 Change control form shall have the following sections as a part of
initiation of a proposed change.
 SUBJECT: This section should describe the details about the change
in which documents / facility / procedure change is required. For
Example: To revise document Number AAA, Title: BBB.
 SCOPE: This section should describe the department / equipment /
document / process name / along with the scope of change i.e. briefly
what the change is about. For Example: To revise document Number
AAA, Title: BBB to incorporate test from current pharmacopoeia.
 REASON FOR CHANGE: In this section the reason / trigger for
which the change is required will be elaborated. This section shall
explain why this change is proposed at the moment. It may include but
will not be limited to, the implication for some other changes, GMP
requirements / change in regulations, addition deletion of equipments,
adoption of new process / test method / protocols, gap analysis during
scheduled revision etc.
 EXISTING PROCEDURE / EQUIPMENT / FACILITY /
DOCUMENT:
 In this section the existing process / facility / procedures in the
documents that are to be changed will be written briefly.
 PROPOSED CHANGE:
 In this section the changes proposed correlating with the
existing system, document should be written.
 IMPACT ANALYSIS:
 In this section the impacts on different aspects like Product,
Process, Stability Regulatory, Validation / Qualification, Training,
 Packaging material, documents or any other parameters / aspects
should be analyzed on a centralized approach not confining to the
particular system / documents which is under change.
 Impact on specifications
 Impact on related documents or Standard Operating
Procedures.
 Change control form shall have the date of implementation of change.
 Change control shall have a date of its final closure along with
compliance of all recommendations thereof.
 All the attachments to a change control should be numbered and
addressed / approved properly.
 LIFE CYCLE OF CHANGE CONTROL
 Change control format should be completely filled and signed by
concerned personnel and then approved by Manager -QA / Designee
before execution and Implementation of change.
 The day the change control is initiated after obtaining a number from
QA until the day it is submitted to QA for review, the change control will
be considered as dormant.
 From the day the change control is reviewed by QA and the day it is
approved, it will be considered under impact analysis.
 This cycle from issuance to approval should not exceed 07 working
days, failing which the issuance of change control shall be cancelled and
the change control shall be invalidated
 The day change control is approved and recommendations are duly
endorsed by the impacted department Manager s, the change control will
 be considered as approved but not implemented. However the
preparatory work for the implementation can be initiated.
 The change control status will be considered open after the
implementation of change until the compliance of the recommendations.
This phase of change control will be crucial as failure to comply with
any of the recommendations may result in retraction of the change.
 If recommendation mentioned in the approved change control not
implemented / No action taken against the approved change control
within one year from the date of approval of change control, then change
control shall be treated as cancelled and new change control shall be fill
whenever required.
 The change control will be closed only after compliance of all
recommendations and approval by the Manager – Quality Assurance.
 The closure of change control should be ideally within 30 days from
the approval date of change control. If not closed within 30 working
day’s initiator department has to submit justification to QA.
 A log for the change control shall be maintained as per Format for
the         keeping the change controls.
 Quarterly Review meeting for change control shall be held by
Manager – QA with Change Control Committee Member to review the
progress or closure of change controls.
 Quality Assurance shall prepare summary of all the change controls
on yearly basis, as per Calendar year – From January to December
 Product specific change control shall be listed in APQR.
 Change control shall be preserved according to SOP for destruction
& storage of documents.