9/7/2010

Pharmaceutical Companies in India Must Deploy Electronic Batch

Record Systems
By: Piyush Dewangan, S.R.Venkatapathy and Rajabahadur V.Arcot

Indian pharmaceutical industry’s domestic market revenues exceeded $12 billion in 2009. The core
strength of the industry is generic drug manufacturing, and India is an established player in the global
generic market. Therefore, the industry has to earn all its margins by efficiently managing all
operations along the production value chain, while ensuring strict compliance with regulations.
Electronic batch record (EBR) systems help pharmaceutical companies to efficiently manage the
complex batch processes, and the resulting documentation must conform to FDA regulations.

Another important requirement of the industry is that pharmaceutical companies must carry out root-
cause-analysis for every batch failure and regulatory authorities mandate this. It is also necessary for
pharmaceutical manufacturers to maintain proper documents and records of the drug development
and approval processes. With supply chains getting extended, the challenge of ensuring product
quality and traceability is becoming more complex. EBR systems empower manufacturers to closely
monitor, record, and document all operations along the value chain, and thus address their
challenges.

Electronic Batch Record system is an efficient way to capture data, exchange batch information, batch
production management, maintain data security and integrity, and report production. While EBR
increases productivity and accuracy of operators, features such as security, audit log generation, and
e-Signature capture, ensures compliance to cGMP requirements, such as FDA 21 CFR part 11 (ER/ES),
210, 211, and 820 (QSR). It facilitates on-line control, batch processing, and provides operator
guidance through SOP’s and signature authorization of the process.

The Online Review Tool (OLRT) of the EBR system enables reviews by exception of the data falling
outside the acceptance limit. It provides complete and accurate documentation and minimizes human
errors through automatic verification of data. It provides a view of production history received from
the manufacturing control system layer, and the interactive review process from quality assurance to
manufacturing paves the way for operational efficiency.

The EBR systems automatically produce electronic reports after completion of each batch and ensure
compliance with QA/QC procedures through routing, line clearances, signatures, test results, and
cross-checks. EBR system provides audit trail services of all production and operational activities.
EBR’s functionality includes security functions and administrative functions that automate enabling
procedures necessary for validation and compliance. It can collaborate with enterprise resource
planning (ERP), laboratory information management system (LIMS), process control system,
manufacturing execution system (MES), and such others.

ARC believes that Indian pharmaceutical companies must evaluate the immediate and long term
benefits of deploying EBR systems. Indian companies have won global recognition as producers and
suppliers of quality pharmaceutical products. It is time for them to invest in technologies that would
help them safeguard the hard earned brand image and scale newer heights and emerge best-in-class
companies globally. While manual recordings and maintenance of records served well in the past,
their future will be shaped by their willingness to leverage technology solutions, such as EBR. Besides
helping companies in meeting the compliance requirements, EBR will help reduce operational costs by
managing recipes, cycle times, and cleaning cycles.

Several leading global automation and IT solution providers in India, such as ABB, Invensys,
SAP, andSiemens, can provide comprehensive solutions in this domain to pharmaceutical
companies. ARC is working on a strategy report that will provide a roadmap for pharmaceutical
companies to emerge best-in-class, and you may write to pdewangan@arcweb.com
/prakasha@arcweb.com for more details.