CHANGE CONTROL INITIATION MATRIX
Change Code
C01
Scope of change
Ownership the change control
Change in building of Manufacturing Block Warehouse Utility Quality Control Microbiology Sterility Test Lab Change in Equipment used for Manufacturing process Change in accessories of equipment e.g. instrument, Motor, stirrer etc (if not like to like)
Operating owner of the building
Consent to be taken from the department other than quality assurance Engineering, Utility and Safety & Environment Environment
Operating owner of the building
Engineering, Utility Safety & Environment Environment
and
QC
Engineering, Utility Safety & Environment Environment
and
Operating owner of the system
Engineering, Manufacturing and Safety & Environment
Manufacturing
Engineering (for site change and equipment usage) and Safety & Environment Environment
Manufacturing
R&D, QC and Safety & Environment (Require R&D Lab Recommendation letter with back up experimental data )
C02
C03
C04
C05
Change in QC testing instrument Change in accessories of QC Instrument (if not like to like)
Change in Critical Utility System (HVAC, Dust Extraction System Water system, Pure steam, Compressed air, Vacuum, Nitrogen and Heating-Cooling System) Manufacturing process: Change of site / stream Change of Batch size Change in equipment usage Manufacturing process: Change in Batch formula Manufacturing process sequence Process parameter In-process control and specification
C06
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 :
[email protected] 00 91 7600134939 / 9327316198
CHANGE CONTROL INITIATION MATRIX
Change Code
C07
Scope of change
Ownership/Initiator of the change control
Material specification Change in Quality Control Raw Material Packing Material Intermediate Finished product Laboratory Chemical Cleaning and sanitization agents Change in Approved Vendor of Purchase RM & Packaging. Material
Consent to be taken from the department other than quality assurance Manufacturing, R&D and Safety & Environment Environment R&D consent is not required for Laboratory chemical and cleaning agents
C08
C09
Change in Artwork and shade cards of printed packing material
Packing development
C10
Change in Packing of Product: Procedure and sequence of packing materials Introduction of new product in the existing manufacturing facility
Packing development
C11
C12
Production
Related departments
C13
Change in Procedures : Standard operating procedure Standard testing procedure General testing procedure Change in Stability program
C14
Change in Validation Protocol
C15
Documentation : Site master file Validation master plan Quality manual Training Module Drawing Formats, which is mentioned as annexure to SOP Soft wares for material movement, Batch release and equipment operation related to the product quality & safety.
Who prepares protocol Quality Assurance
R&D, Manufacturing, QC, Warehouse and Safety & Environment Manufacturing, Quality Control, and Safety & Environment Manufacturing, Quality Control, and Safety & Environment QC, Engineering, R&D Warehouse, Purchase, and Safety & Environment Environment All related Departments
Quality Control the
Manufacturing and Safety & Environment Applicable department All Approving authority
C16 C17 C 18
Engineering & Utility Operating owner
Owner of the system drawn Related Department
Operating owner
EDP
