change control initiation matrix
TRANSCRIPT
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8/3/2019 Change Control Initiation Matrix
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CHANGE CONTROL INITIATION MATRIX
Change
Code
Scope of change Ownership the change
control
Consent to be taken from
the department other than
quality assurance
C01 Change in building of
Manufacturing Block
Warehouse Utility Quality Control Microbiology Sterility Test
Lab
Operating owner of the
building
Engineering, Utility and
Safety & Environment
C02 Change in Equipment used forManufacturing process
Change in accessories ofequipment e.g. instrument,
Motor, stirrer etc (if not like to
like)
Operating owner of the
building
Engineering, Utility and
Safety & Environment
C03 Change in QC testinginstrument
Change in accessories of QCInstrument (if not like to like)
QC Engineering, Utility and
Safety & Environment
C04 Change in Critical Utility System
(HVAC, Dust Extraction System
Water system, Pure steam,
Compressed air, Vacuum, Nitrogen
and Heating-Cooling System)
Operating owner of the
system
Engineering, Manufacturing
and Safety & Environment
C05 Manufacturing process:
Change of site / stream Change of Batch size Change in equipment usage
Manufacturing Engineering (for site change
and equipment usage) andSafety & Environment
C06 Manufacturing process:
Change in
Batch formula Manufacturing process
sequence
Process parameter In-process control and
specification
Manufacturing R&D, QC and Safety &
Environment
(Require R&D Lab
Recommendation letter with
back up experimental data )
DR PREM R GOEL
BSc,B.Pharm,M.Pharm[India]
MS,Ph.D[Pharma][USA]MBA[USA]MIQA[UK]
[email protected] Skype:gaoposher
[email protected] MSN MESSENGER
00 91 7600134939 / 9327316198
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8/3/2019 Change Control Initiation Matrix
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CHANGE CONTROL INITIATION MATRIX
Change
Code
Scope of change Ownership/Initiator of
the change control
Consent to be taken from
the department other than
quality assurance
C07 Material specification Change in
Raw Material Packing Material Intermediate Finished product Laboratory Chemical Cleaning and sanitization
agents
Quality Control Manufacturing, R&D and
Safety & Environment
R&D consent is not required
for Laboratory chemical and
cleaning agents
C08 Change in Approved Vendor of
RM & Packaging. Material
Purchase R&D, Manufacturing, QC,
Warehouse and Safety &
Environment
C09 Change in Artwork and shade
cards of printed packing material
Packing development Manufacturing, Quality
Control, and Safety &
EnvironmentC10 Change in Packing of Product:
Procedure and sequence of packing
materials
Packing development Manufacturing, Quality
Control, and Safety &
Environment
C11 Introduction of new product in the
existing manufacturing facility
Production QC, Engineering, R&D
Warehouse, Purchase, and
Safety & Environment
C12 Change in Procedures :
Standard operating procedure Standard testing procedure General testing procedure
Related departments All related Departments
C13 Change in Stability program Quality Control Manufacturing and Safety &
EnvironmentC14 Change in Validation Protocol Who prepares the
protocol
Applicable department
C15 Documentation :
Site master file Validation master plan Quality manual Training Module
Quality Assurance All Approving authority
C16 Drawing Engineering & Utility Owner of the system drawn
C17 Formats, which is mentioned as
annexure to SOP
Operating owner Related Department
C 18 Soft wares for material movement,
Batch release and equipment
operation related to the product
quality & safety.
Operating owner EDP