SAP Active Ingredient Management and Dose Calculation for Biologics/Life Sciences/Pharmaceuticals

SAP Active Ingredient Management Solutionfor

Biologics / Life Sciences / Pharmaceuticals

• SAP ECC 6.0/ERP 6.0

SAP Solution BriefSAP Solution Brief

IndexSynopsis11

Industry Requirements22 Industry Requirements22

IT Sapiens’ Solution Features33

IT Sapiens’ Solution Set44

IT Sapiens’ Solution Features Demo55

Solution Merits66

Our Value Proposition77

1Questions ?88

p

March 6th 2015 ©2014 IT Sapiens, Inc. Proprietary and Confidential

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


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

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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…)March 6th 2015 ©2014 IT Sapiens, Inc.

Proprietary and Confidential


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

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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…)March 6th 2015 ©2014 IT Sapiens, Inc.



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

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(…Contd)


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..)March 6th 2015 ©2014 IT Sapiens, Inc.



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

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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.



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)



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 maintenanceP 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

9March 6th 2015 ©2014 IT Sapiens, Inc.


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…)


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



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.)

IT Sapiens’ Solution Features Demo – Master Data55

Ability to Maintain “Boost” and “Actual Potency Range” per Material:

11 (Contd…)

(Contd..)



Ability to Maintain Actual “Potency” per Material Batch:

12 (Contd…)

(..Contd..)March 6th 2015 ©2014 IT Sapiens, Inc.



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 :


Proprietary and Confidential (Contd…)

IT Sapiens’ Solution Features Demo – Inventory55

System wide Material Batch Inventory visibility (Txn MMBE) in Doses and in Dimensional and Non-Dimensional Units of Measure and vice-versa

14 (Contd…)March 6th 2015 ©2014 IT Sapiens, Inc.


IT Sapiens’ Solution Features Demo – Inventory55

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



IT Sapiens’ Solution Features Demo – Planning55

Linear or Proportional Conversion to Doses during Planning since Active Ingredient Batch does not exist for Dependent Requirements



IT Sapiens’ Solution Features Demo – Manufacturing Master Data55

Bulk Material Bill of Material with Active Ingredients and Buffers / Fillers / Excipients

Active Ingredients Buffers/Fillers/Excipients

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Controlled Recipe with Batch Balancing Formulae

Active Ingredients Buffers/Fillers/Excipients

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Controlled Recipe with Batch Balancing Formulae to adjust Buffer/Filler quantities

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IT Sapiens’ Solution Features Demo – Manufacturing Execution55

Materials and Operations in Process Order NOT Changeable

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Planned Active Ingredient requirement quantities in Doses and Milliliter based on Master Data (Production Version BOM and Recipe)

21




Strict sequence of Batch Determination enforced Active Ingredients first, then Buffers/Fillers/etc. so that “Batch Balancing” can be carried out

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cGMP Compliant Batch Determination for Active Ingredient with availability in Doses

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cGMP Compliant Batch Determination for Active Ingredient components

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Active Ingredients requirement quantity adjusted per Batch “Actual Potency” of Batch determined and assigned (compare with slide 21 for prior values)

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Buffers/Fillers requirement quantities AFTER Active Ingredient Batch determination and assignment and BEFORE “Batch Balancing”

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Buffers/Fillers requirement quantities AFTER Active Ingredient Batch determination and assignment and AFTER “Batch Balancing”

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Buffers/Fillers Batches determined too and Process Order is ready to Release and create Control Recipe

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IT Sapiens’ Solution Features Demo – Component Material Staging for Manufacturing55

Active Ingredient Material Staging requests in Milliliter

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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 ECMPPPI E ti I t ti cGMP compliant Custom functionality for ECMPPPI 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


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 and y p g y pdeep 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

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Framework to develop strawman solutions Our “Say-To Do” Ratio is 1:1


Questions ?88

For more information…kindly contact Vijay PisipatyDirector-ERP Solutions & ConsultingIT Sapiens, Inc.e-mail: [email protected]



Technology

SAP Active Ingredient Management and Dose Calculation for Biologics/Life Sciences/Pharmaceuticals