API MANUFACTURING PROCESS CHANGE ANALYSIS MATRIX

Preapproval registration Stability Accelerated / long term

Lab Data backup/Tre nd data

Changing being effected

Approval from RA dept.

Training

Level of change*

Changes

BPR/ MFR change

Annual report submission

Exp. Study on Con

Process Validation

Batch Formula a) Change of Route of Mfg b) Inclusion /Delection of RM C) Change in RM quantity Manufacturing Process Sequence Change of mfg. Route Sequence of material additions in critical steps of Intermediate stage manufacturing. Sequence of material addition in non critical steps of Intermediate stage manufacturing. Sequence of material additions in critical steps of Final stage manufacturing of molecule formation or purification.

03 03 03

X X X

03 02

01

03

Vendor audit
X X X X X X X

API MANUFACTURING PROCESS CHANGE ANALYSIS MATRIX

Preapproval registration Stability Accelerated / long term

Lab Data backup/Tre nd data

Changing being effected

Approval from RA dept.

Training

Level of change*

Changes

BPR/ MFR change

Annual report submission

Exp. Study on Con

Process Validation

Sequence of material addition in non critical steps of Final stage manufacturing of molecule formation or purification. Change in the number of intermediate stages with out changing Mfg route. Process Parameter Critical Non Critical In Process Control Test Inclusion or deletion of test parameter Change In Specification Change of batch size Change of Site without change in equipment train FOR Non Sterile Within facility Within premises Out of premise. Change of Equipment

01

03

02 01

X X

X X

X X X

X X

X X

01 01 01

X X X

X X X

X X X

X X X

Long Term

01 02 03

X X

X X X

Vendor audit
X X X X X X X X X X

API MANUFACTURING PROCESS CHANGE ANALYSIS MATRIX

Preapproval registration Stability Accelerated / long term

Lab Data backup/Tre nd data

Changing being effected

Approval from RA dept.

Training
X X X X X X

Level of change*

Changes

BPR/ MFR change

Annual report submission

Exp. Study on Con

Process Validation

Equipment having same configuration Capacity change with no change in shape and operating principle. change in operating principle. Change of Material Change in the starting & key Raw material Specification Change in the Specification of Intermediate Change of vendor of starting raw material Change of vendor of raw material other than starting raw material Change in specification Material and configuration of construction of primary packing material Change in other specification parameter of primary packing material

Long Term

01 02 03

Long term

02 01 03 01

X X

03

Long term

01

Vendor audit
X X X X X X

API MANUFACTURING PROCESS CHANGE ANALYSIS MATRIX

Preapproval registration Stability Accelerated / long term

Lab Data backup/Tre nd data

Changing being effected

Approval from RA dept.

Training
X X X X

Level of change*

Changes

BPR/ MFR change

Annual report submission

Exp. Study on Con

Process Validation

Change in the vendor of Primary packing Material Change in the specification of Secondary packing material Change in product label artwork and shade card Change in sequence of secondary packing material Change in the specification of Finished Product

02 01 01 01 --

X X

X X

X X

X X

X X

X X

*Definition of Level of Changes: Level 1 : Are those that are unlikely to have any detectable impact on the quality attributes of the product Level 2; Are those could have a significant impact on the quality attributes of the product Level 3 : Are those that are likely to have a significant impact on the quality attributes of the product

Vendor audit
X X X X