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CHANGE CONTROL INITIATION MATRIX

Change Code C01

Scope of change

C02

Change in building of Manufacturing Block Warehouse Utility Quality Control Microbiology Sterility Test Lab Change in Equipment used for Operating owner of the Engineering, Utility building Safety & Environment Manufacturing process Change in accessories of equipment e.g. instrument, Motor, stirrer etc (if not like to like) Change in QC testing QC instrument Change in accessories of QC Instrument (if not like to like)

Consent to be taken from the department other than quality assurance Operating owner of the Engineering, Utility and building Safety & Environment

Ownership the change control

and

C03

Engineering, Utility Safety & Environment

and

C04

C05

C06

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

Operating owner of the Engineering, Manufacturing system and Safety & Environment

Manufacturing

Engineering (for site change and equipment usage) and Safety & Environment R&D, QC and Safety & Environment (Require R&D Lab Recommendation letter with back up experimental data )

Manufacturing

DR PREM R GOEL BSc,B.Pharm,M.Pharm[India] MS,Ph.D[Pharma][USA]MBA[USA]MIQA[UK] drpremrgoel@gmail.com Skype:gaoposher goelngoelassociatesplc@gmail.com MSN MESSENGER :drpremrgoel1947@hotmail.com 00 91 7600134939 / 9327316198

CHANGE CONTROL INITIATION MATRIX

Change Code C07

Scope of change

Ownership/Initiator of the change control

C08

Quality Control Material specification Change in Raw Material Packing Material Intermediate Finished product Laboratory Chemical Cleaning and sanitization agents Change in Approved Vendor of Purchase RM & Packaging. Material Change in Artwork and shade Packing development cards of printed packing material Change in Packing of Product: Packing development Procedure and sequence of packing materials Introduction of new product in the Production existing manufacturing facility Change in Procedures : Standard operating procedure Standard testing procedure General testing procedure Change in Stability program Change in Validation Protocol Related departments

Consent to be taken from the department other than quality assurance Manufacturing, R&D and Safety & Environment R&D consent is not required for Laboratory chemical and cleaning agents

C09

C10

C11

C12

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 All related Departments

C13 C14 C15

Quality Control Who prepares protocol Quality Assurance

Manufacturing and Safety & Environment the Applicable department All Approving authority

C16 C17 C 18

Documentation : Site master file Validation master plan Quality manual Training Module Drawing Engineering & Utility Formats, which is mentioned as Operating owner annexure to SOP Soft wares for material movement, Operating owner Batch release and equipment operation related to the product quality & safety.

Owner of the system drawn Related Department EDP

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