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CastaLife

An Enterprise-wide Solution for Pharmaceutical Industries on SAP S/4HANA

Pharma Manufacturing: An Overview

India is the largest provider of generic drugs globally. India supplies over 50% of global vaccine demand for various vaccines, 40% of generic demand in the US & 25% of all medicine in the UK. By Oct ’20, India exported Pharmaceuticals worth US$ 16.3 billion. By 2025, Indian pharmaceutical sector is expected to grow to US$ 100 billion.  Medicine spending is projected to grow 9-12% in the next five years.

Indian Pharma manufacturing industry is quite large with more than 3000 pharma companies with more than 10,500 manufacturing facilities producing thousands of products.

Main pharma product categories manufactured in India

Intermediates

Used for producing APIs or Bulk drugs (API Intermediates and Advanced Intermediates)

Biologics & Biosimilars

Large, complex proteins made from living cells (bacterial and viral vaccines, proteins, serums, plasmas etc.)

APIs / Bulk Drugs

The basic drug with required medicinal properties (Aspirin, caffeine, Paclitaxel, etc.)

Excipients

Act as carriers of API drug (used in capsules, tablets, oral liquids, inhalers, implants and injections

Formulations

Finished drugs consumed by us whether branded or generic drugs (oral, parenteral, topical, oncological, novel drugs etc.)

Major types of pharma businesses in India

Main Line

Large pharma organizations with large research infrastructure & personnel, manufacturing facilities, a wide range of product lines and several patents

CRAMS Providers

Contract Research & Manufacturing Services Providers which help Mainline companies in research, clinical trials, mass production of bulk drugs, intermediates & formulations

Generic drug manufacturers

Manufacturers that produce low-cost drugs in high volumes after expiry of patent

Challenges faced by Pharma Industries

Highly regulated local & international environments

Cost of compliance is high and the cost of non-compliance is way too much higher

Lower Profit Margins lead to negligible investment in product R & D

Lack of research approach and good GxPs (Good Manufacturing Practices, Good Clinical Practices, Good Laboratory Practices etc.)

No tolerance to deviations in quality of drugs, necessitating highly efficient quality assurance & control practices

Finally, a Supply Chain & Workforce which is a on long way to recovery from the impact of Covid-19

Dependence on China for API & other input material, specially for generic drugs

Future Opportunities for Pharma Industries

Huge Market for existing and new businesses; Pharma industry in India expected to reach USD 65 billions by 2024 and to USD 120 billions by 2030

Contract research and manufacturing services industry is growing very fast with Bulk of requirements come from the US, UK & Europe due to a large technically knowledgeable workforce, WHO-GMP production facilities and lower cost of production

Increasing Opportunities in Bio-similars with domestic market expected to reach USD 2.2 billions by 2025. Also, new opportunities may come up when the patents of several biologic drugs expire in future.

Increasing focus on Pharma Industry by our government by taking measures such as Setting up Bulk Drug Parks, Granting Production Linked Incentives, Developing R & D skills, Allowing 100% FDI in Greenfield and Brownfield Projects etc.

Increasing FDI opportunities, with an inflow of USD 16.86 billion between Apr '20 & Sep '20

As a drug manufacturer, you need a system which helps you in building an efficient Supply Chain while running Production and Quality processes that help you deliver quality drugs on promised dates to your customers. The system should help you in your product research journey as well as local and international compliances. You should be able to monitor your business real-time and respond to any situation immediately..

Keeping these challenges and opportunities in perspective, we have designed and developed a solution on SAP ERP – CastaLife specifically for Pharma manufacturers, which is being used by several organizations in India 

Our Solution

Components, Functions & Features of our solution for Pharmaceutical Industry

An enterprise application for Pharma manufacturing should enable organizations to produce and deliver high quality products to its customers quickly and at competitive prices, while following CGMP practices and complying with various regulations (FDA, HACCP etc.). It should also help organizations to analyze how their products are being used by customers, and support or service them where required.

Our solution CastaLife is specifically designed to do this! Our team of business experts with vast experience in Pharmaceutical Industry have identified major requirements and developed this pre-configured solution, certified by SAP SE. Whether you are a Contract Manufacturer, Research organization or Generic drug producer, you can use our solution to run your business with good practices (CxP) for manufacturing, clinical, laboratory, storage & distribution of your material.

Our solution enhances the capabilities of SAP S/4HANA and helps you in managing your sales, production, quality & logistic processes specific to pharma industry apart from supporting back office functions like accounting and human resources. We constantly update our solution with improved planning & scheduling processes along with latest compliance requirements and release them in the form of service packs.

Major components of our solution are listed below.

Baseline Solution

Preconfigured Cross Industry processes on SAP ECC or S/4HANA

Pharma Add-on

Add-on Solution with Pharma Processes & Analytics

Other SAP Apps

SAP Analytics Cloud, Concur Travel & Expenses, SuccessFactors, Fiori, Solution Manager etc.

Baseline Functions

Cross-Industry Functions & Features on SAP ECC or SAP S/4HANA

Standard processes across functions such as Finance, Sourcing & Procurement, Sales, Supply Chain, Quality Management, Production etc. are pre-configured and available for use readily. All processes are available with local tax compliance and reporting requirements. 

For example, processes such as procurement of raw material, assets, services etc. are already configured with various release strategies and Purchase Order layouts with the required tax procedures. Processes supporting Domestic Sales, Exports, Online Sales etc. along with invoice layouts are already pre-configured and available to use. Chart of Accounts that supports local and international reporting requirements are available along with the Legal & Statutory reporting templates.

Ready-made tools are available to migrate your Master data and open items. Analytical reports across various functions are readily available.

You can adapt to these pre-configured processes or customize where required and start using the solution quickly. The Baseline functions included in this solution are listed below.

SAP S/4HANA
Finance

for managing receivables, payables, finance closing & reporting

SAP S/4HANA
Sourcing & Procurement

for managing suppliers, buying material and sources

SAP S/4HANA
Supply Chain

for managing Inventory, Delivery, Transportation and Warehousing

SAP S/4HANA
Sales

for managing customers, pricing, orders, and contracts

SAP S/4HANA
Manufacturing

for production planning, scheduling & operations, managing quality

SAP S/4HANA
Asset Management

for equipment maintenance planning and operations

SAP S/4HANA
Service

for managing customer support & complaints

SAP S/4HANA
R&D / Engineering

for new Product Research & Development

SAP S/4HANA
Embedded Analytics

for using built-in analytics across sales, finance, purchasing etc.

SAP S/4HANA
Digital Compliance platform

for taxes, legal & regulatory reporting specific to India

Pharma Addon

An add-on solution for Pharmaceutical Industry on SAP ECC or S/4HANA

Apart from the baselines functions, we have included processes and features which are specific to Pharmaceutical Industry. These features are available to organizations producing Intermediates, Bulk Drugs or APIs, Formulations, Biologics & Excipients. 

Using the native functions & features of SAP ERP, we have incorporated features to support CxP practices related to Manufacturing, Laboratory, Clinical, Distribution and Storage of all material used in drug production. All these practices support various local and international compliance requirements such as FDA, EU, MHRA, HACCP. We have specifically considered the Computer System Validation requirements of US FDA, while developing this solution.

Some of the important features specific to Pharmaceutical Industry are listed below.

Master Data Governance

Batch Management & Tracing

Label Management

Warehouse Management with Handheld devices

Managing electronic records

IT Validation (DQ, IQ, OQ, PQ)

Customer-specific packaging & labelling instructions, which are different from your standards

Production as per cGMP Guidelines

Quantity conversion between various Unit of Measurements

Use of Batch Attributes across procurement, quality, production and sales processes

Data Security & Integrity

Audit Trail and Traceability i.e. trace the production of a specific batch of drug backwards

US FDA, WHO-GMP, EDQM, HACCP & REACH compliance

Other SAP Applications

Add more capability to your Pharma Solution on SAP ERP

In addition to the Baseline solution & Pharma Add-ons, you can implement additional SAP Applications listed below which are customized for Pharmaceutical Industry.

SAP Success Factors

for managing core HR functions, Payroll, Talent, Learning along with Workforce planning and Analytics

SAP Fiori

for enabling several transactions, reports & analytics on IOS devices

SAP Concur

for planning, requests, approvals and analysis of business & travel expenses incurred by your personnel

SAP Solution Manager

for Document Management, Test Management, Incident Management & Integrative Change Management

SAP Analytics Cloud

for Descriptive, Diagnostic, Predictive & Prescriptive Analytics of your business

Connect with our Pharma Industry experts to implement our Pharmaceutical Solution on SAP ERP - whether ECC or S4/HANA.