Reference SOP No.
: QA-XXX/NN
Company Name Company Logo
Reference To Categorization And Impact Assessment Of Changes
Following are the Details of Changes but not limited to:
Brief Description of Changes Category Approval Should be Obtained From
1.0 Process Change:
Changing the total manufacturing Process RA, QA, QC, EHS, Engg. & Production
(Different synthetic Scheme) Major
Changing one or more non critical Raw RA, QA, QC, EHS, & Production
Minor/Major
Materials.
Changing one or more critical Raw RA, QA, QC, EHS, & Production
Major
Materials.
Changing the input ratios of raw RA, QA, EHS, & Production
Minor
Materials <10%
Changing the input ratios of raw RA, QA, QC, EHS, & Production
Major
Materials >10%
Changing the operating parameters like RA, QA, EHS, & Production
temperature, pressure, duration in certain
operations like reflux or maintenance of Major
reaction mixture at certain
temperature/pressure etc.
Replacing the existing equipment Same: 1. In case of Production Equipment - RA,
reactors, Pumps, Agitated Filters, Driers, Minor QA, EHS, Engg. & Production
Blenders, Pulverizer) with new Different: 2. In case of QC Equipment – QA, RA, and
equipment of same or different design. Major QC
Changing the building design and layout. Major RA, QA, EHS, Engg. & Production
Changing the pipe lines/valves(used for RA, QA, EHS, Engg. & Production
transferring raw materials, in process
Minor or
materials, intermediates, finished product
Major
and services like water, steam brine,
vacuum and compressed air)
Change in utility Minor/Major RA ,QA ,EHS ,Engg.& Production
Specification and testing methods of raw RA, QA, QC, & Production
Materials, in process, intermediates, Major
finished Product and stability.
Prepared By Checked By Approved By
Name
Department
Signature
Date
Issued by : Copy No. :
(Sign/date )
Page 1 of 2 F1/QA-XXX/NN
Reference SOP No. : QA-XXX/NN
Company Name Company Logo
Reference To Categorization And Impact Assessment Of Changes
2.0 Document Changes
1) System Manual Head QA
2) SOPs Respective Dept. HOD/Head QA
3) STPs/Specification/Method of Minor Related Dept. Head & QA
Analysis
4) Forms Related Dept. Head & QA
3.0 Other Changes
Change in Manufacturing Site Major QA, Engg. Production & RA
Reprocessing /Recovery Procedures Major RA, Production, QA & QC
Supplier of KSM Major QC,QA, Production & Purchase
Supplier of Non –KSM Minor QC,QA, Production & Purchase
Change in Primary Packing Material and QC,QA, Production & Purchase
Major
Vendor
Change in Secondary Packing Material QC,QA, Production & Purchase
Minor
and Vendor
● RA: Regulatory Affairs (RA) approvals are required for changes to process filed in DMF. So in case
if there is no submission then QA – Head is authorized to sign in place of RA.
Prepared By Checked By Approved By
Name
Department
Signature
Date
Issued by : Copy No. :
(Sign/date )
Page 2 of 2 F1/QA-XXX/NN
