Express Pharma

‘Serialisation needs careful assessment’

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Pradeep Dhargalkar, Head-Packaging Development, Unichem Laboratories, talks about the implementation of serialisation and challenges to pharma companies, in a discussion with Sachin Jagdale

How did your company approach the serialisation project? Can you outline 10 steps to get started with serialisation?

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Pradeep Dhargalkar

In the adoption of global track and trace regulations to protect patient safety and ensure product integrity, serialisation is common across most adopted regulations. 10 steps to get started with serialisation are:

  • Create reusable serial number generation profiles for all product types, logistical units (item, case, bundle, pallet) and market destinations
  • Support global standard and country-specific formats to create GS1 standard formats (SGTIN, SSCC)
  • Generate custom formats for places like Brazil and import custom formats
  • Manage and monitor allocations automatically for all packaging codes by defining serial number creation rules for request limits, minimum thresholds, uniqueness checks, randomisation requirements
  • Establish a common interface to capture and respond to provisioning requests from internal packaging sites and external CMO/ CPO partners using dozens of diverse line management systems
  • Manage serialised inventory operations such as product movement capture or pharmaceutical product aggregation changes across plant and warehouse operations whether they are internal locations or executed at CMO or 3PL partner locations
  • Trigger compliance activities resulting from serialised product events to meet traceability data exchange or government reporting requirements.
  • Manufacturers, wholesale distributors, dispensers and repackagers must pass, capture and maintain certain information with respect to each transaction
  • Emphasis should be on lot-level info (vs. SNI or unit)
  • Now ‘pedigree’ or ‘product tracing’ requirements are triggered by changes in ownership (or transactions) between trading partners

Were there any gaps in the implementation process that showed up in the pilot testing phase? Could you share the learnings and how your company went about setting it right?

Serialisation addresses several challenges facing supply chain security in today’s global marketplace:

  • Controlling and monitoring a highly complex distribution network from manufacturers to consumers in which products change hands as many as 10 times
  • Authentication of the product at various levels in the supply chain becomes very difficult without data sharing across the supply chain
  • Current business processes are very labour-intensive and, as a result, the price paid by the consumer for pharma products is high
  • The high price of prescription drugs and the relative ease of duplication and diversion make them a prime target for counterfeiters.

What are the issues faced by project leaders in terms of training staff, etc? Does India have skilled talent at these levels on the packaging lines, software IT departments?

Serialisation needs careful assessment, diligent planning and swift implementation. This white paper offers pharma company’s critical information on leveraging global best practices when implementing serialisation. Serialisation involves optimum utilisation of existing technologies/ machineries. Employees must be trained to handle the new equipment.

What are the implications of a serialisation project in terms of line and plant level software?

It requires significant investment to validate the packaging line, beyond process and equipment validation.  Managing and administering serialisation is a complex process that leads to additional cost if not managed properly. Key operational challenges include:

  • Creation of unique serialisation codes for individual products during the production process
  • High-speed printing and verification of the codes generated

What should a company keep in mind when preparing for and rolling out the pilot testing phase?

Most companies are just evaluating how they want to move forward. Serialisation will force packagers not only to upgrade manufacturing Execution Systems (MES) but to integrate new hardware and software with serialisation and traceability and back office Enterprise Resource Planning (ERP) systems, responsible for managing serial numbers and business data sent to the packaging line.

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