BatchMaster for Pharmaceuticals

BatchMaster Manufacturingfor 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 ChallengesDevelop 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 – PharmaA 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

BMM for SAP Business One can help you 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

BMM for SAP Business One can help you 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

BMM for SAP Business One can help you 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 Manufacturingfor SAP Business One

A complete, proven ERP Software for Food & Beverages Manufacturers


Date post:	11-Jan-2017
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