SOP FOR HANDLING OF CHANGE

CONTROL
1. OBJECTIVE

To lay down a procedure to describe the handling of change

control which include the procedure for initiation, evaluation,
review, approval/ rejection of proposed change, Implementation
of the approved changes and its post implementation.

 SCOPE

2.1 This procedure is applicable for handling of change control.

 This procedure covers (but not limited to) the change in product
quality / reproducibility, facility, utilities and / or support systems,
process equipment, / instrument including computer data storage
device / software, manufacturing formula, manufacturing / packing
process & parameters,

process environment or manufacturing site, standard batch

size, specification, analytical methods,

vendor / suppliers, raw / packing material, artworks, process

aids, holding period; storage and

distribution of product, documentation including validation

master plan, validation reports, qualification protocol and reports, new
material / product introduction, SOP’s, site master file.

 RESPONSIBILITY

Officer/ Executive of initiating

Initiating Department :
department

Evaluation : Officer/ Executive QA

 Compliance : Head initiating department and QA Head

Authorization : Plant Head

 ACCOUNTABILITY

Head Quality Assurance: for implementation and system

compliance

 PROCEDURE

 Change control is “a formal system by which qualified representatives

of appropriate disciplines shall review proposed or actual changes that
might affect a validated status. The intent is to determine the need for
action that would ensure and document that the system is maintained
in a validated state.” Change is also defined as addition/ deletion in the
existing validated system.
 The proposal for change from the existing system, facility, standard
procedures / practices and document updation shall be initiated by the
officer / Executive of respective department. The same shall be
reviewed by Department head with proper justification for the
proposed change and shall be forwarded to QA department for its
evaluation based on the justification and supporting data.
 Change control covers the following criteria but not limited to:
 Facility Related

 Manufacturing Process Related

Changes in batch size, batch formula, manufacturing steps/

instructions, process parameters, in-process controls, primary packing,
pack specification and pack size etc.

Change in the specification of Raw materials (including

active, excipients, solvent, reagent and catalysts) In-process, Finished
Product, Change in Analytical or Microbiological test procedures
(STP/GTP), Stability Protocol, Analytical Method Validation (if
 applicable) and any other which may directly/ indirectly affect the
product quality; Changes in Packing Material specification, Art work
and other printed packaging material shall be requested to be routed
through Change Management process.

 Stability

Extension of the shelf life based on the available stability

data and change in storage condition, Stability Program etc.

 Documentation Related

Change in SOP, formats, Batch Records,

Validation Protocol, Stability Protocol, Site Master File, Validation Maser
Plan, Quality Manual or any other documents, Changes in drawings
related to facility and utilities etc.

 Others

Changes in Vendor, source of raw material /

primary packing material, Bill of material etc., Changes proposed by
marketing based on the feedback from customers. Changes proposed
by production department for improving the packing / presentation of
the product, changes proposed by Distribution or changes due to
change in Registration profiles. Changes due to updation in
Pharmacopoeia, changes due to introduction of new guidelines or
cGMP requirements. Compliance issues, CAPA practices/ Procedural
changes.

 Issuance of Change Control format:

 The format of Change control shall be issued by QA on the written
request by respective departments.
 In case of any additional prints/ page are required then respective
department shall raise requisition for additional page. QA shall issue
additional page.
 Initiation of change control

The change control shall be initiated by the concerned department

Officer/ Executive and checked by concern department head. Initiator
shall cover the following points:
 Date of Initiation and Initiating Department
 Product / System/ Material / Specification/ Analytical procedures/
Process/ Documents/ Others (if applicable )
 Proposed Change: A brief outline of the proposed change.
 Reason for proposing Change/ Basis / Reference /Justification/
Rationale (may include, but not limited to the following:
 Regulatory requirement based on guidelines, GMP / GLP improvement,
Compliance to audit observation, Capacity enhancement, Expansion /
renovation of the facility, man material movement, Process
automation, Improvement suggested by marketing department, CAPA
taken as the outcome of the investigation conducted, Environmental
conditions improvement, personnel skill improvement.
 Necessary supporting documents to justify the proposed change as
applicable shall be attached with the Change Control format (if
applicable).
 Evaluation of change control
 Numbering of the Change Controls

On receipt of the filled change control format, QA department shall

allot a number to the respective change control and shall log in the
Change control log format. Every change control shall be allotted a
number consisting of eight characters as follows:

CC/DC/YY/MM/XXX

Where, CC- Change Control

DC – Department Code

YY – last 2 digit of current Year (19 for 2019, 20 for 2020)

MM – Month (01 for Jan., 02 for February, 03 for March………………….12

for Dec.)

XXX – Serial Number of the change control in respective month.

Example:

The first change control occurring in the Quality Control Department in

month of March 2019 shall be numbered as: CC/QC/19/03/001.
 QA Head/ designee shall assess the impact of the change proposal on:
 Product quality/ Systems /GMP.
 Validation/ Qualification
 Process/ Quality Parameter
 Documentation
 Stability
 Vendor/ Source of material
 Regulatory Aspect
 Training
 Pack Specification
 Any other procedural change, which may have reflection of the
proposed change.
 The impact of the proposed changes on documents as listed shall also
be done (but not limited to) i.e. MFR/ BMR/ BFR/ BPR, SOP, Item codes,
Specification/ STP, Validation/ Qualification Protocol/ Validation Master
Plan/ Calibration Master Plan/ Cleaning Procedures/ Analytical Method
Validation, Stability Program / Protocol, Formats, Drawing (s), facility
layouts, Technical Agreement (s), Site Master File, Log books/ records.

 Any other, such as change in batch number coding system.

 As part of the evaluation of the proposed change, identification for the
actions as listed below shall also be evaluated:
 Validation Trial/ Experimental Batch Manufacturing
 Qualification (IQ/OQ/PQ)
 Charging product on stability
 Need of training
 Prior Approval/ Information/ Notification to Regulatory Body/ Business
Partner/ Key customer (s)/ internal information to other Departments.

 Development of any new procedure / method.

 Based on the evaluation, QA shall classify the change as Critical/ Major/

Minor.
 Classification of Change
 Critical :

Changes that may have direct or significant impact on product quality

such as, but not limited to:

 Change related to process parameters

 Change related to primary packing material
 Stability requirements
 Source of API and key excipients
 Change in environmental conditions that affect the product quality and
stability.
 Change in cleaning procedure
 Change in manufacturing formulation.
 Major:

Changes that may have an impact on product quality, termed as Major

changes. Such as modification in the facility, Utility systems, addition
or replacement of equipment, or any other change which has impact
on the product quality and major modifications for enhancement of
GMP/ GLP at the site.

 Minor:

Changes that may not have direct impact on product quality, is termed
as Minor changes. Such as changes in the recording formats, changes
in the site SOPs, improvement in validation documents, change in
secondary or tertiary packing material, minor changes in the
Equipment, Utility systems, facility for enhancement of GMP/ GLP at
the site, changes in specifications (not affecting product quality).

 During review QA Head shall request any further information/ data

supporting the proposed change from initiator if required.
 Based on the review, QA Head shall identify the department /
personnel whose comments / opinion or evaluation is required for the
proposed change, based on the nature of change. This may include,
but not limited to Production, Quality Control, Ware House, Purchase,
Marketing, Engineering, Personnel & Administration, Projects or any
other as applicable.
 QA Head shall forward Change Control to the initiator for getting
evaluation by the identified internal departments/ personnel.
 After completion of the evaluation by all concerned departments,
initiator shall forward the Change Control to QA for approval.
 In case the change proposed, requires evaluation / approval from
Regulatory Affairs, customer or any other department which is not
operating at the site, the site QA shall send the scanned copy of the
change control to the relevant department. After evaluation, that
department shall give his comment, acceptance or rejection on the
format and shall send same back to the respective site.
 Regulatory department shall evaluate the proposed change and shall
identify the requirement for the following, prior to approval of change
by considering the regulatory implication, if required:
 Notification of change to customer/ Agency
 Obtaining approval of change by customer
 Regulatory filing
 Approval of Change
 Based on the comments and evaluation done by QA Head, Plant Head
or his designee shall approve/ reject the proposed change control.
 In case of disagreements on decision for recommending the change
among identified evaluators, the final decision shall be taken by Plant
Head with proper justification.
 In case the change is not approved, Plant Head or designee shall give
reason for not approving the proposal. The same information shall be
updated in the change control log book and the change control format
shall be return to department head from where the proposal was
initiated.

 Implementation of Change

 QA Head shall communicate the same to initiator to implement the

approved change.

 Initiator shall refer the details of instructions/ comments/ actions/

documents as advised by QA in Change Control format.

 The relevant documents shall be revised and approved change shall be

implemented.
 Department head shall ensure the implementation as authorized by
Plant Head.

 Post Implementation Evaluation

 As per need determined by QA, changes shall be evaluated after

implementation to check whether objective of the change has been
achieved.

 The initiator department shall submit all supporting data/ information

to QA for evaluation.

 If the data / information of post implementation is found satisfactory,

Plant Head shall authorize for regularization of the change. In case the
 data /information is not satisfactory, QA shall advise to return to the
original procedure/ practice and discontinuation of the approved
change.
 Closure of the Change Control

After the post implementation evaluation of change

implemented, QA Head/ designee shall close the change control after:

 Ensuring results and supporting data

 Completion of the required activities / documents identified during the
evaluation and approval of change.
 The change control log register shall be maintained.
 The filled change control format and change control log shall be kept
with QA department.

 Trending of Change control:

 Continuous trending of the change control shall be carried out.
 QA shall carry out the trend analysis for all the whole year change
control, at the beginning of the next year. A copy of trend analysis
shall be forwarded to Head Quality.
 The trending shall be carried out for the changes to be done as minor,
major and critical changes. However the trending of the major and
critical changes shall be done, like facility related, document related,
product related, Machine related etc.

6.0 TRAINING

Trainer : Head – Quality Assurance

Trainees : Staff of all the departments

7.0 DISTRIBUTION

Master Copy : Quality Assurance

Controlled Copy : Quality Assurance

8.0 ATTACHMENT

Sr. No. Annexure No. Title Format No.

 1 NA NA NA

9.0 REFERENCES

In-house

10.0 ABBREVIATION

Abbreviation Extended Form

EG Engineering

SOP Standard Operating Procedure

QA Quality Assurance

WH Warehouse

NA Not Applicable

MB Microbiology

11.0 REVISION HISTORY OF CHANGE

Sr. No. Date Revision Details Revision No.

1 NA NA NA