To lay down the procedure for Change Control. Change control involves evaluating and approving changes in the project baseline scope.
2.0 SCOPE
2.1 This procedure applies to the Quality Assurance Department of Xyz.
3.0 RESPONSIBILITIES
3.1 Chemists
of QA to follow the SOP.
3.2 Head
– QA complies with SOP.
4.0 PROCEDURE
4.1 CHANGE CONTROL:
Change control is defined as the process of influencing the factors that create
change, determining that a change has occurred, and managing the actual changes
when they occur.
4.1.1 Major Change
Change may
have an impact on the identity, quality, purity, strength, stability, safety efficacy, or physical characteristics of the product.
4.1.2 Minor Change
Change, may not have an impact on the identity, quality, purity, strength, stability, safety, efficacy, or physical characteristics of the product.
4.2 PROCEDURE
4.2.1 Raise
change control proposal for any permanent change as described in SOP.
4.2.2 The
department/section head should submit the proposal for change in a “Proposal
for Change / Modification” format. The change or amendment shall be
recorded in “Amendment in the document” format.
4.2.3 Change in the manufacturing process, and process control parameters for
yield/quality improvement.
4.2.4 Change
in manufacturing formula, raw material, and packaging material.
4.2.5 Change
in equipment, and utilities.
4.2.6 Change
in labeling, and packaging material.
4.2.7 Change
in Specifications/Standard Operating Procedures.
4.2.8 Change/up-gradation
in data recording/controlling system.
4.2.9 Relocation
of facility/equipment.
4.2.10 The head of the originating department shall propose the change to Head – Quality
Assurance, along with supporting data (as applicable).
4.2.11 Details
of required changes in other documents (e.g. labels, specifications, SOPs).
4.2.12 Head
– Originating department and Head – Quality Assurance shall judge
the feasibility of the proposed change based on supporting data and
historical data if available.
4.2.13 Quality
Assurance shall give the change control number and shall make entries in
the “Change Control Record” format.
4.2.14 After the assessment of the change proposal, Head-Quality Assurance shall classify the
change as a major or minor category.
4.2.15 The
impact of the proposed change shall be discussed and the necessary action plan
shall be documented along with the responsibility and target date. Compliance with
the action plan shall be reviewed during the approval of the change proposal
and closure.
4.2.16 The respective department shall review the change control proposal, as mentioned in the
format, “Proposal for Change/ Modification” and the required support shall be
attached.
4.2.17 Head–Quality Assurance shall review the change proposal.
4.2.18 based on justification, scientific rationale, and supporting data, the Head – of Quality Assurance and Factory Manager shall approve or reject the change
proposal.
4.2.19 Depending
on the extent of evaluation and nature of the proposed change, the Head- of Quality
Assurance shall forward the approved change proposal to the Factory Manager for
approval.
4.2.20 After
approval from the Factory manager, The “Proposal for Change/ Modification”
format should be reviewed approved, and authorized by the Head of Quality
assurance and the Factory manager.
4.2.21 Before
the implementation of the approved change proposal, training shall be given to
all concerned personnel. (A copy of such training record shall be attached to the
change proposal).
4.2.22 Approval or rejection of the proposal shall be communicated to the originating
department by forwarding a photocopy of the approved/rejected change control
proposal.
4.2.23 After the implementation of the change, data (as applicable) shall be collected by the
originating department and shall be reviewed by Quality Assurance.
4.2.24 After the evaluation of data, the Head – Of Quality Assurance shall close the change
proposal.
4.2.25
Completed change control formats and the associated documents should be
maintained as history.
4.2.26 Minor
changes in the Master documents such as spelling corrections, and revision/addition
of one or two steps in the SOPs, shall be made through “Amendment” and the
corrections shall be regularized during the next revision.
4.2.27 The numbering system for the change control proposal is as follows:
4.2.28 The change control, proposal number shall be given by Quality Assurance after
receipt of “Proposal for Change/ Modification” from the respective department.
4.2.29 The
change control proposal number will start from “CCP/YYY/201_/01”, and
onwards. Where CCP denotes, “Change Control
Proposal” YY or YYY denotes Department Code“201_” denotes Year and
followed by/for separation and then the sequence of CCP number in two
digits “01”.
4.2.30 The
change control origination and details shall be given as per the “Change
Control Record (Year…..)” format.
4.2.31
Specifications/SOPs/STPs that are being revised during scheduled review need
not be routed through the change control proposal.
5.0 ABBREVIATIONS
CCP:
Change Control Proposal
GTP: General Test Procedure
PD: Process Development
QA: Quality Assurance
QC: Quality Control
SOP: Standard Operating Procedure
STP: Standard Test Procedure
6.1 Nil