There now exists an IT Sapiens developed, comprehensive "SAP Active Ingredient Management Solution for Biologics/Life Sciences/Pharmaceuticals", that is cGMP compliant and caters to "Exponential" Conversion of Milliliter, Liters, etc to Doses.

1. SAP Active Ingredient Management Solution
for
Biologics / Life Sciences / Pharmaceuticals
• SAP ECC 6.0/ERP 6.0
SAP Solution BriefSAP Solution Brief

2. Index
Synopsis11
Industry Requirements22 Industry Requirements22
IT Sapiens’ Solution Features33
IT Sapiens’ Solution Set44
IT Sapiens’ Solution Features Demo55
Solution Merits66
Our Value Proposition77
1
Questions ?88
p
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3. Synopsis11
 Biologics / Life Sciences / Pharmaceuticals Industry:
 Products consist of Active Ingredient and Fillers / Buffers / Excipients
 Active Ingredients are usually handled in Dimensional and Non-Dimensional Units of
Measure
 e.g. Dimensional Units of Measure include:
 Milliliter, Liter, etc
 Milligram, Gram, etc
 e.g. Non- Dimensional Units of Measure include:
 Each, Thousands, Case, Bottle, etc
 Conversion from Dimensional and Non-Dimensional Units of Measure to Doses is
usually complex and “Non-Linear” (i.e. not proportional), and could be “logarithmic”
or “exponential” too, and is dependent on other parameters such as “Boost” and
“Potency” of Active Ingredient Lot
 Controlled Spreadsheets are commonly used for calculation of Active Ingredient
Batch specific Doses from Dimensional and Non-Dimensional Units of Measure, for
2
purposes of Inventory look-up and for “Batch Balancing” in the Manufacturing
Execution Process
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4. Industry Requirements for Active Ingredient Management22
 Common Industry Requirements for SAP Active Ingredient Management:
 Master Data:
 Need ability to maintain Theoretical Potency (a.k.a “Boost”) per Material
 Need ability to maintain Actual Potency (a.k.a “Potency”) per Material Batch
 Need ability to automatically convert Material Batch specific Dimensional & Non-
Dimensional Units of Measure to Doses and vice-versa, using “Exponential”
conversion rules, based on “Boost” and “Potency” of the Material Batch
 Need ability to create a “Controlled” Bulk Material Bill-of-Material with Active
Ingredients and Buffers/Fillers/Excipients as components
C ’ f Need all changes to Controlled Bulk Material’s Bill of Material to be permitted
ONLY with “Engineering Change Management” driven approval
 Inventory:
N d E t i id M t i l B t h I t i ibilit i D d i Need Enterprise wide Material Batch Inventory visibility in Doses and in
Dimensional and Non-Dimensional Units of Measure and vice-versa
 Planning:
 For Planning purposes need ability to maintain conversion rules for conversion
3
 For Planning purposes, need ability to maintain conversion rules for conversion
from Dimensional and Non-Dimensional Units of Measure to Doses and vice-
versa
(Contd…)
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5. Industry Requirements for Active Ingredient Management22
 Common Industry Requirements for SAP Active Ingredient Management:
 Manufacturing:
 Need ability to restrict changes to Bulk Material Manufacturing Order
components List and components quantities (i.e. need a Controlled Recipe)
 In Bulk Material Manufacturing Order, need ability to automatically determine
Active Ingredient Material Batches based on FEFO and other criteria, and Active
Ingredient component requirement quantity needs to automatically adjust based
on Potency of the Batch assigned
 In Manufacturing Order, need ability to prevent to Buffer/Filler/Excipient Material
Batch determination or Batch assigned until all Active Ingredient Material
Batches are determined and assigned
 In Manufacturing Order, need ability to execute “Batch Balancing” (a.k.a.
M t i l Q tit C l l ti ) t t ti ll dj t B ff /Fill /E i i tMaterial Quantity Calculation) to automatically adjust Buffer/Filler/Excipient
Material quantity requirements, based on Active Ingredient Material Batches
quantities picked
 In Manufacturing Order need ability to prevent Buffer/Filler/Excipient Material
4
 In Manufacturing Order, need ability to prevent Buffer/Filler/Excipient Material
Batch determination or Batch assignment until all Active Ingredient Material
Batches are determined and assigned, and Batch Balancing is executed
(..Contd…)
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6. Industry Requirements for Active Ingredient Management22
 Common Industry Requirements for SAP Active Ingredient Management:
 Component Material Staging for Manufacturing:
 Need ability to pick and stage component material batch quantities in Milliter or
Liter or Grams or Kilgrams or Pounds
 Need ability to post consumption of staged component material batch quantities
in Milliter or Liter or Grams or Kilgrams or Pounds
5
(…Contd)
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7. IT Sapiens’ SAP Active Ingredient Management
– Solution Features33
 Following are IT Sapiens’ SAP Active Ingredient Management Solution features:
 Master Data:
 Provides ability to maintain Theoretical Potency (a.k.a “Boost”) per Material
 Provides ability to maintain Actual Potency (a.k.a “Potency”) per Material Batch
 Provides ability to automatically “Exponentially” convert Material Batch specific
Dimensional and Non-Dimensional Units of Measure to Doses and vice-versa,
based on “Boost” and “Potency” of the Material Batch
 Provides ability to create of “Controlled” Bulk Material Bill-of-Material with Active
Ingredients and Buffers/Fillers/Excipients as components
 C f O Provides ability to carry out all changes to Controlled Bill of ONLY with
“Engineering Change Management” driven prior approval
 Inventory:
 P id E t i id M t i l B t h I t i ibilit i D d i Provides Enterprise wide Material Batch Inventory visibility in Doses and in
Dimensional and Non-Dimensional Units of Measure and vice-versa
 Planning:
 For Planning purposes provides ability to maintain conversion rules for
6
 For Planning purposes, provides ability to maintain conversion rules for
conversion from Dimensional and Non-Dimensional Units of Measure to Doses
and vice-versa
(..Contd..)
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Proprietary and Confidential

8. IT Sapiens’ SAP Active Ingredient Management
– Solution Features
33
 Following are IT Sapiens’ SAP Active Ingredient Management Solution features:
 Manufacturing:
 Provides ability to restrict changes to Manufacturing Order components List and
components quantities (i.e. provides “Controlled Recipe” functionality)
 In Manufacturing Order, provides ability to automatically determine Active
Ingredient Material Batches based on FEFO and other criteria, an component
requirement quantity needs to automatically adjust based on Potency of the Batch
assigned to Component
 In Manufacturing Order, provides ability to prevent Buffer/Filler/Excipient Material
Batch determination or Batch assigned until all Active Ingredient Material Batches
are determined and assigned
 In Manufacturing Order, provides ability to execute “Batch Balancing” (a.k.a.
M t i l Q tit C l l ti ) t t ti ll dj t B ff /Fill /E i i tMaterial Quantity Calculation) to automatically adjust Buffer/Filler/Excipient
Material quantity requirements, based on Active Ingredient Material Batches
quantities picked
 In Manufacturing Order provides ability to prevents Buffer/Filler/Excipient Material
7
 In Manufacturing Order, provides ability to prevents Buffer/Filler/Excipient Material
Batch determination or Batch assignment until all Active Ingredient Material
Batches are determined and assigned, and Batch Balancing is executed
(..Contd…)
March 6th 2015 ©2014 IT Sapiens, Inc.
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9. IT Sapiens’ SAP Active Ingredient Management
– Solution Features
33
 Following are IT Sapiens’ SAP Active Ingredient Management Solution features:
 Component Material Staging for Manufacturing:
 Provides ability to pick and stage component material batch quantities in Milliliter
or Liter or Grams or Kilograms or Pounds
 Provides ability to post consumption of staged component material batch
quantities in Milliliter or Liter or Grams or Kilograms or Pounds
8
(…Contd)
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10. IT Sapiens’ Solution Set44
 Following IT Sapiens’ SAP Solution Set delivers Industry desired functionality:
 Master Data:
 Material Masters
 Batch Characteristics and Classes
 Bill of Material, Recipe, Production Version
 Change Control:
 Engineering Change Request and Engineering Change Order with Digital
Signatures for:
 Batch Characteristics and Classes Changes
 Bill f M i l Ch Bill of Material Changes
 Production Version Changes
 Custom Authorization Objects for Characteristic Value maintenance
P d ti /P E ti Production/Process Execution:
 “Controlled Recipes” that cannot be changed during execution
 Custom developed tight Integration between PPPI-Process Execution and
Engineering Change Management that prevents unreleased unapproved and
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Engineering Change Management that prevents unreleased, unapproved and
work in process Master Data changes (e.g. Recipe, BOM) from being adopted
into the Process Order (Contd…)

11. IT Sapiens’ Solution Set44
 Following IT Sapiens’ SAP Solution Set delivers Industry desired functionality:
 Production/Process Execution:
 Custom functionality that enforces sequence of Components’ Batch
Determination in Process Order (i.e. Active Ingredient Batch determination before
Excipient/Filler/Buffer Batch Determination)
 Seamless conversion of Doses to Volume or Weight Units of measure
 Custom “Batch Balancing” functionality that works with “Control Recipes” and
allows or auto adjustment of Excipient/Filler/Buffer requirement quantity based on
Active Ingredient Batches assigned
I t Inventory:
 Functionality that delivers system wide seamless conversion of Active Ingredient
Batch quantities from Dimensional and Non-Dimensional Units of Measure to
D d Vi VDoses and Vice Versa
 Planning:
 Formula for baseline conversion of Active Ingredient quantities from Dimensional
and Non Dimensional Units of Measure to Doses and Vice Versa for situations
10
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and Non-Dimensional Units of Measure to Doses and Vice Versa, for situations
where a Active Ingredient Batch does not exist (e.g. Dependent Requirements,
Order Reservations, etc
(..Contd.)

12. IT Sapiens’ Solution Features Demo
– Master Data
55
 Ability to Maintain “Boost” and “Actual Potency Range” per Material:
11 (Contd…)
(Contd..)
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13. IT Sapiens’ Solution Features Demo
– Master Data
55
 Ability to Maintain Actual “Potency” per Material Batch:
12 (Contd…)
(..Contd..)
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14. IT Sapiens’ Solution Features Demo
– Master Data
55
 Ability to automatically and Exponentially convert Material Batch specific
Dimensional and Non-Dimensional Units of Measure to Doses and vice-versa,
based on “Boost” and “Potency” of the Material Batch :
13
March 6th 2015 ©2014 IT Sapiens, Inc.
Proprietary and Confidential (Contd…)

15. IT Sapiens’ Solution Features Demo
– Inventory
55
 System wide Material Batch Inventory visibility (Txn MMBE) in Doses and in
Dimensional and Non-Dimensional Units of Measure and vice-versa
14 (Contd…)
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16. IT Sapiens’ Solution Features Demo
– Inventory
55
 System wide Material Batch Inventory visibility (Txn MD04) in Doses and in
Dimensional and Non-Dimensional Units of Measure and vice-versa
Sum of All Material Batch
Inventory in Doses
15 (Contd…)
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17. IT Sapiens’ Solution Features Demo
– Planning
55
 Linear or Proportional Conversion to Doses during Planning since Active
Ingredient Batch does not exist for Dependent Requirements
16 (Contd…)
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18. IT Sapiens’ Solution Features Demo
– Manufacturing Master Data
55
 Bulk Material Bill of Material with Active Ingredients and Buffers / Fillers /
Excipients
Active Ingredients Buffers/Fillers/Excipients
17
(Contd…)
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19. IT Sapiens’ Solution Features Demo
– Manufacturing Master Data
55
 Controlled Recipe with Batch Balancing Formulae
Active Ingredients Buffers/Fillers/Excipients
18
(Contd…)
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20. IT Sapiens’ Solution Features Demo
– Manufacturing Master Data
55
 Controlled Recipe with Batch Balancing Formulae to adjust Buffer/Filler
quantities
19
(Contd…)
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21. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 Materials and Operations in Process Order NOT Changeable
20
(Contd…)
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22. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 Planned Active Ingredient requirement quantities in Doses and Milliliter based
on Master Data (Production Version  BOM and Recipe)
21
(Contd…)
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23. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 Strict sequence of Batch Determination enforced  Active Ingredients first,
then Buffers/Fillers/etc. so that “Batch Balancing” can be carried out
22
(Contd…)
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24. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 cGMP Compliant Batch Determination for Active Ingredient with availability in
Doses
23
(Contd…)
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25. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 cGMP Compliant Batch Determination for Active Ingredient components
24
(Contd…)
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26. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 Active Ingredients requirement quantity adjusted per Batch “Actual Potency”
of Batch determined and assigned (compare with slide 21 for prior values)
25
(Contd…)
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27. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 Buffers/Fillers requirement quantities AFTER Active Ingredient Batch
determination and assignment and BEFORE “Batch Balancing”
26
(Contd…)
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28. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 Buffers/Fillers requirement quantities AFTER Active Ingredient Batch
determination and assignment and AFTER “Batch Balancing”
27
(Contd…)
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29. IT Sapiens’ Solution Features Demo
– Manufacturing Execution
55
 Buffers/Fillers Batches determined too and Process Order is ready to Release
and create Control Recipe
28
(Contd…)
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30. IT Sapiens’ Solution Features Demo
– Component Material Staging for Manufacturing
55
 Active Ingredient Material Staging requests in Milliliter
29
(Contd…)
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31. Solution Merits66
 IT Sapiens’ “SAP Active Ingredient Management Solution” Merits:
 Seamlessly provides system wide, Linear and “Exponential” conversion of Active
Ingredient Material Batch quantities from Dimensional and Non-Dimensional Units of
Measure to Doses and vice-versa
 Replaces the use of external tools & controlled spread sheets for qty conversion
 Provides “Controlled” and cGMP compliant functionality across Logistics processes
and provides real-time benefits:
 Master Data Maintenance
 Inventory Management
 Manufacturing Execution
 Material Staging
 Ability to Interact with MES systems using “Control Recipes”
GMP li t C t f ti lit f ECMPPPI E ti I t ti cGMP compliant Custom functionality for ECMPPPI Execution Integration
 Functionality is dynamic enough that, using configuration and master data, it can
seamlessly extendable to any line of business (e.g. Human Vaccines, Human
Injectables Animal Health etc)
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Injectables, Animal Health, etc)
 Functionality involves NO SAP SOURCE CODE MODIFICATION
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32. Our Value Proposition77
 Reduced TCO, Highest First Pass Yield and Highest Quality from:
 Strong expertise in providing end-to-end Supply Chain Solutions
 Strong Expertise implementing SAP, enriching Business processes and
alleviating GAPs in SAP, for Biologics / Life Sciences, Consumer Products,
Pharmaceutical, Chemical and High-Tech Industry segments
 Very experienced consulting resource base with 13+ years experience andy p g y p
deep cross-functional expertise
 Rich Knowledge base of custom solutions to address GAPs in most SAP
applicationspp
 Ability to demonstrate end-state on Day 1 using in-house SAP Systems rich
with:
 Pre-configured SolutionsPre configured Solutions
 demo-able SAP Functionality
 Demo-able IT Sapiens custom solutions
 Framework to develop strawman solutions
31
 Framework to develop strawman solutions
 Our “Say-To Do” Ratio is 1:1
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33. Questions ?88
 For more information…kindly contact
Vijay Pisipaty
Director-ERP Solutions & Consulting
IT Sapiens, Inc.
e-mail: vijay.pisipaty@itsapiens.com
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