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September 28, 2010

RFID in Pharma Manufacturing and Regulatory Compliance

What has helped retailers eliminate costs, manage assets and provide self checkout facility to customers? What has eliminated multiple resource requirements for handling and tracking packages and parcels in transport industry? What has off late reduced the burden of manual intervention at the toll gates?

No reward for guessing and it is RFID (Radio-frequency identification). Simply put, RFID (also sometimes referred to as Auto ID) outlines a technique of identifying an entity relevant to business, by use of radio waves (with the help of RFID tags and tag readers). Now various industries have seen multi faced utility of RFID. Let's assess its usage in Pharma Manufacturing with focus on regulatory compliance.

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September 24, 2010

Challenges for Pharma Contract Manufacturer Organizations

Pharma companies are trying to outsource more and more manufacturing activities to contract manufactures so that they can focus on core activities of drug discovery and marketing. One estimate pegs the annual revenue from contract manufacturing and research activities to approximately 180 Billion USD for year 2010 with the annual growth rate of approximately 11%.There is a rapid rise in the pharma contract manufacturing organizations in India and China in recent years and this will further aid to the growth of the contract manufacturing industry. The blog explorers various challenges that CMOs are likely to face in medium to long term timeframe.

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September 17, 2010

Service Introduction- In IT space

The concept 'Service Introduction' is gaining rapid popularity in IT world as an 'effective tool' to introduce a new application/service into an established system.

In short, Service Introduction is the management of activities to ensure that applications/systems being developed to meet all operational requirements before getting introduced to 'Production or Live' environment. It also has to ensure 'Maintenance teams' are comfortable in providing the required services from the day one.

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March 23, 2010

Optimize Operating Cost of Pharma ERP Support Setup

This blog is based on the experience of working in Pharma ERP Projects and Support environment. In this case ERP system used was is SAP R/3 system. One of the observation is Pharma companies have to follow and built in Validation and Compliance steps in both SAP Projects and  Production Support processes. Validation and Compliance ensures detailed electronic records and audit trails are maintained for system setup, design, specifications, testing, defects, modifications and are ensured through Validation Plan & Report for SAP Projects and through Validation Audits for SAP Production System. Validation and Compliance procedures also ensures Implementation and Maintenance of GxP business processes as per defined operating procedures in the underlying systems. This translates into presence of multiple tools and presence of complex processes which adds up to the cost of SAP Support setup. This blog examines and present ways to reduce such costs.

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March 17, 2010

ERP Consolidation Assessment in Pharma Companies:Cross-Divisional or Divisional

Pharma and Healthcare companies may have multiple ERP system lines in their Organization. This could be because of multiple reasons, for example how organization was structured in the past e.g. separate business divisions exist for patent drug production, Generics, Consumer Health or it would have acquired or got merged with other Pharma companies for better strategic fitment. Reasons apart, there is sufficient scope to optimize the total cost of ownership of ERP Systems by consolidation into a Global ERP System. Apart from the benefits arising from IT Infrastructure consolidation, the business case for consolidation of ERP systems will originate from the top management need of having a global view of business, to foster the standardization of the business processes across divisions, to improve visibility across supply chain, to bring efficiency in handling inter-divisional transactions and most importantly to emerge as a customer and market responsive organization.

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February 13, 2010

Pharma Complaint Management:Meeting the Challenges

Inadequate handling and management of Product complaints is one of the top findings in the FDA warning letters to the Pharma and Healthcare companies. Though these companies have Complaint Management systems and procedures in place but clearly there is a need for robust solution to meet the challenges of regulatory compliance, having an advance alert mechanism for relevant business decisions on account of product safety and most importantly of being responsive to customer and regulatory authorities.

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