BatchMaster for Pharmaceuticals

BatchMaster Manufacturing
for SAP Business One
A complete, proven ERP Software for Nutraceutical & Pharmaceutical Manufacturers

Pharmaceutical Industry Ecosystem

 Indian Pharmaceutical industry,
third largest in terms of volume and
biggest foreign supplier of
medicines to the US
 Positive outlook for this sector,
impressive export turnover spread
across 200 countries and has huge
local market.
 200 FDA-approved drug
manufacturing facilities
 Currently, India's image as a
supplier of safe and quality
medicines at affordable prices is
under tight scrutiny.
Business
STRATEGY
YOUR FOCUS
•Attention to details on
regulatory compliance
•Drive for lower costs
•Improve Profit Margins
•Improve Customer
Satisfaction
Pharmaceutical Industries Often have the Right Focus and
the Right Strategies…

Market Forces and Business Needs
Market Forces
 Retailer power
 Consumer concerns about quality drugs;
Reliable composition
 Increased legislation and regulations around
drug safety by the FDA and other authorities
 Quicker and preventive /corrective actions
 Shorter product life cycles
 Extreme price pressure and margin erosion
 Restrictive consumer spending pattern
 Market consolidation (globalization, M&As)
 Increasing competition
 Emerging private labels
Resulting Key Challenges
Develop new products faster and more
effectively
Optimize supply chain
Increase efficiency in procurement
Optimize manufacturing
Ensure drug safety and regulatory
compliance
Improve sales efficiency

The Challenges. The Solution. The Capabilities.
End-to-End ERP Solution for Nutraceuticals & Pharmaceuticals
BatchMaster Manufacturing for SAP Business One

BatchMaster ERP – Pharma
A Complete Enterprise Solution
BatchMaster ERP PharmaBatchMaster ERP Pharma

BatchMaster Manufacturing (BMM) for SAP Business One
• Complete, functional fit ERP solution for Nutraceutical & Pharmaceutical Industry
• A process-manufacturing add-on for SAP Business One
• In-built and not integrated
• Single database, Single Interface and Single Login
• Tailor made to meet industry’s niche requirements
• Supports complete value chain from product development, formula management, procurement,
inventory management, batch processing, quality control to compliance and sales
• Industries Served:

• The only, process ERP software preconfigured to
manufacture soft gelatin capsules/ tablets/powders, etc.
• Complete support for development of new
products/formulations for contract manufacturing with
enhanced features like specialized costing and quotation.
• Very efficient planning and scheduling (MPS / MRP)
modules: to reduce inventory holding cost and to ensure
that there are no shortages of raw materials during
production.
Differentiators: Business Features
BMM SAP B1 Pharma Micro-vertical

• Supplier management and verification features in
accordance with regulatory requirements
• Permits purchase of cGMP material from Item specific
vendors only
• Printing of supplement fact sheets as per FDA approved
formats with allergen information
• Capturing of real time batch monitoring information and
SOP activities through “inspection plan” and “inspection
check list “modules
• Electronic batch ticket, Electronic weigh sheet and Batch
Manufacturing record
Differentiators: Regulatory Features

• FDA 21 CFR Part 11 compliance.
• Inventory module equipped with lot traceability, lot recall,
shelf life management, etc.
• Formula security, Formula Revision Control, approval
system, change log, provision of viewing current active
formula with prior versions on the same screen, distinct
formula status for R&D and production.
• Well-defined QC and QA roles for tight control over the
movement of the material within production in alignment
with cGMP requirements

• Advanced Quality Control module: sampling plan, stability
testing for shelf life, retesting of inventory at any time
• Auto generation of Non-conformance for QC and inspection
plan failed items for QA disposition
• Corrective and Preventive Action (CAPA) module for
determination of root cause analysis of nonconformance
items and to track corrective and preventive action
• Adverse event reporting module for complaints, adverse
events and actions taken
• Printing of release/ reject, on hold labels, scrap/ vendor
nonconformance reports by QA

Develop New Products Faster and More Effectively
 Compliance and reporting
requirements
 Develop drugs efficiently
& with precision
 Formula and lot
management to optimize
the inventory
Challenges
 Enable collaborative
engineering
 Consolidate product
development data and
documents
 Reduce development
effort and time-to-market
Strategies
 Integrated Laboratory Module
 Approval process for controlled Product
Development
 MSDS and Certificate of Analysis generation
 Integrated Manufacturing SOP
 Allergen Management
BMM for SAP Business One can help you
 Better insight into costing by
what-if cost analysis
 Proper product and by-
product management
 Multi currency and multi
language support
Benefits

Optimize Formula Management
 Have a Formula for every
product size
 Maintain various versions of
a formula in excel
 Track formulas & compare
with older version
 Formula Roll back
Challenges
 To have a centralized tool to
securely maintain & store
various formulas
 To get rid of cumbersome
excel sheets for maintaining
formulas
 Secure formulas
Strategies
 Provides a sophisticated tool for formula
management
 Formula Versions with Audit Log
 Easy tracking & comparison of various
formula versions within a few clicks
 Improved operational
excellence
 Lower capital commitment
 Reduced operating costs
 Higher customer
satisfaction
Benefits

Increase Efficiency in Procurement
 Managing suppliers & their
certifications
 Cope with ever-changing
quality of the raw material
 Manage complex payment
conditions
 Create operational
efficiencies & transparency
Challenges
 Reduce costs
 Streamline processes
 Gain more visibility and
transparency
 Improve relationship with
producers
Strategies
 Set up integrated and flexible processes
for procurement
 Ensure integrated quality management
 Supplier Management
 Procurement from certified vendors
 Track batches
 Increased demand planning
accuracy
 Consistent internal and
external procurement reporting
 Integrated processes
Benefits

Ensure Drug Safety and Regulatory Compliance
 Align with governmental
regulations (GMP, FDA,
BMR, CAPA, US.
Bioterrorism Act of 2002,
Adverse Event Reporting)
 Enable fast, effective
product recalls
 Track and trace
Challenges
 Support mid- and long-term
company success by
ensuring regulatory
compliance
 Set efficient processes in
place to enable traceability
 Allow targeted product recalls
to minimize costs
Strategies
 Track, monitor, and trace batches and
inventory
 Streamline procurement, production, and
sales
 HACCP Compliant Production
 Manage sales returns
 Enable targeted product recalls
 Reduced penalty risk
 Decreased risk of food-safety
compensation payments
 Reduced risk of bad reputation
 Lower operating costs
Benefits

Product Development
End-to-End ERP Solution for Nutraceutical & Pharmaceutical
• Opportunity tracking and new sample management
with real costs and quotations
• Developing safe and reliable drugs based on fixed
formulas
• Examine all the FDA regulations & perform CAPA
accordingly
• Separate costing of formula & packaging to
accommodate packaging requirements
• Manufacturing SOP
• Ingredient Information
• Support for development of new
products/formulations for contract manufacturing
• Catch Weight Functionality
• Allergen Management

Formula Management – Formula Revision
• Formula Security
• Formula versioning with audit log
• Approval for revised formulations
• Formula comparison with roll back
options
• Embedded Quality Control
• Provision of defining specifications and
ability to generate reports

Master Production Scheduling
• Planning Calendar
• Formula Process Cell Capacity
• Forecast Maintenance
• MPS Dashboard
• MPS Worksheet
• MPS Production Order
• Grouping & Sorting
• Combine Orders
• Direct transfer of MPS
orders to Production Orders

Material Requirement Planning
• Lead Time Calculation based on
procurement & QC check time
• MRP Dashboard
• MRP Worksheet
• Sorting & Grouping
• Consolidation of Orders
• Transfer to Purchase Orders

Goods Receipt & Incoming QC
End-to-End ERP Solution for Food & Beverages
• Handles Quote to Receipt to
Voucher
• Permits Partial Receipts
• Multiple lot receipt details can be
seen through Relationship Map
• Auto-generation of QC orders upon
good receipts
• Goods can be released or rejected
as per QC results
• Perform QC/QA on received goods
as per cGMP guidelines

Production Execution
• Batch Ticket
• Batch Sizing Options
• Actual Raw Material Consumption
• Modification to Batch List
• Issue Raw Materials
• FG Assign Lot
• Production QC
• Rework Batch
• Partial & Full Close
• FG Label print

Inventory Management
 Manage inventory based upon costing,
quality status, units of measure, expiration
date, lot number, strength, serial number and
location
 Ensure that the right inventory is available for
manufacturing and distribution activities
 Avoid cross contamination by quality status
and lot tracking
 Run real-time inventory valuation, availability
checks, standard and special pricing to make
the best use of available resources

Quality Control & Quality Assurance
• Tight control over the movement of material as per cGMP
norms through bin management and quality control
statuses
• Advanced Quality Control module: sampling plan, stability
testing for shelf life, retesting of inventory at any time
• Well defined QC and QA roles. Complete traceability of
QC pass/ fail material and its real time cost implications
• Provision to maintain RM/WIP/FG quality specifications
and its testing to ensure consistent quality
• Generation of customer specific COA with real QC results
• Auto generation of non-conformance for failed QC tests
with provision of CAPA
• Supports electronic execution of SOPs and capturing of
batch monitoring activities with time stamping
• HACCP implementation through inspection plan

Sales Order Processing
• Ease of search for customer information
• Drill Down to customer for history information
• Automated Price List based on Price Rules
• Multiple UOM handling for sales documents
• Multi-Currency support
• Document attachment on Sales Order
• Print sales order layout output
• Allows part delivery and configurable over delivery
• Shipment tracking
• Automated shipping and billing details fetched from
Customer Master
• Automated inventory update after delivery and real
time JV entry for accounts
• Invoice generation

Financial Reporting
• Standard Financial Reports
• General Ledger
• Trial Balance
• Cash Flow
• Business Partner Aging
• Maintain multiple templates for Financial
reports
• Periodic reporting
• Financial reports comparison

Simple Design of Your Marketing Documents
• Powerful and easy to use
design tool
• Flexible output
management and export
capabilities
(PDF, e-mail and fax
support)
• SAP provides ready-to-
use marketing templates
SAP Business One offers extended editing and
printing functionality for all marketing documents

Opportunities Pipeline
The Opportunity Pipeline analyzes the
open sales opportunities and dynamic
graphic shows the development of the
sales opportunities.

Thank You!
BatchMaster Manufacturing
for SAP Business One
A complete, proven ERP Software for Food & Beverages Manufacturers

BatchMaster for Pharmaceuticals

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