Training

Role of QA in ERP
 Contents
• Creation of codes for different forms of
material
• Packing / Repacking BOM
• Batch numbering
Types of materials in manufacturing

• Raw materials / Packing materials

• Intermediates/Rework/Purification (stages /
Bi-products/ Cleaning reprocess)
• Finished goods
• 2nd Crop, 3rd crop……
• Materials with different forms/ grades
( eg. Milled / EP / USP)
 Raw / Packing materials
• 01-01-AAAAA ( Commercial Grade )
• 01-02-AAAAA ( LR Grade )
• 01-03-AAAAA ( AR Grade )
• 98-001-AAAA ( Gases )
• 02-01-AAAAA ( Packing material )
 Coding
• Manufactured intermediates

 Stages
Stage-1 - 03-01-00AAA1
Stage-2 - 03-01-00AAA2
Stage-3 - 03-01-00AAA3

 Bulk drug( API )

Final stage - 03-01-000AAA

 Bi products
Bi product1 - 03-01-00AAA
Bi product2 - 03-02-00AAA
Bi product3 - 03-03-00AAA , So on
 Coding
• Manufactured intermediates
 Crops
2nd crop - 03-01-00AXXX
3rd crop - 03-01-00BXXX
4th crop - 03-01-00CXXX , So on

 Intermediates for sale

For PTN - 03-01-00XXX1
After PKg - 03-0P-00XXX1

 Purification
Main product - 03-01-00AAAP
2nd crop - 03-01-0AXXXP & as per stage

 Reprocess Any product - 03-01-00XXXR

 Rework Any product - 03-01-0XXXRW

 Coding
• Finished Goods
 As per Grades
IP - 04-0A-000XXX
BP - 04-0B-000XXX
USP - 04-0C-000XXX So on & the series of middle
no. Will depend and
managed by on site QA

 Different forms
Jetmilled - 04-01-00AAAJ
Blending - 04-01-00AAAB
 Packing and Repacking
• Flow of Batch

Stage-1 Stage-2 Stage-3

Packed product Final

Packing/Repacking
eg.04-0A-000GEM eg.03-01-000GEM

Packed product
eg.03-0P-000GEM
Batch Numbering
 Batch Numbering

Batch Name

B.no
Site

Material Prd. blk Year

 Batch Numbering
• All that is manufactured in plant shall be
allotted batch no. as follows ( Normal )
AAXXXYYZZMMM , where
AA – Location/ Site
XXX – Product code / Abbreviation
YY – Plant number / Production Block
ZZ – Year
MMM – Sequential no/ Serial no
Questions