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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.

Taking a step back, we already see the usage of RFID in Pharma in various pre-manufacturing phases of product lifecycle, such as handling manufacturing raw material and in Supply chain management. Asset management, tracking the candidate artifacts, warehouse management are areas where we already see the usage of RFID in terms of tracing the materials, tracing its locus within the storehouse and manufacturing units, etc. Apart from this, RFID has also added value in Supply chain management in terms of tracking orders, maintaining reorder levels, accuracy of orders, quality control and warranty / maintenance of the same.

RFID has spread its tentacles into various other related forums of importance to business. Post manufacturing for example sees the importance of RFID in terms of ensuring shelf availability of popular products, self checkout facility for the customer, checking theft and tracks product returns and recalls. This has made several organizations realize the benefit and huge potential of RFID technology even with experimental partial implementation and it's ROI.

Joining dots from Asset management, Supply chain management and Consumer we would like to assess how manufacturing can leverage RFID technology. In particular, let's see how RFID can help in Pharma Manufacturing from the compliance perspective.

Firstly let's get to know what makes Pharma manufacturing special and different from other manufacturing industries. Apart from many other differences, Pharma manufacturing comes with a burden of catering to various regulatory and incorporation of best practices to the process and thereby provides sufficient proof to the assessing / auditing regulatory authority of the foolproof manufacturing of the products. Investment that goes into ensuring the same is enormous and as these are being done manually or semi-manually, there are a lot of areas where automation of processes with non-intervention of manual workforce can maximized.

Apart from many other generic advantages, RFID can go a long way in enforcing and facilitating implementation of regulatory compliance guidelines and CGMP (Current Good Manufacturing Practice).

· RFID could be a technique to ensure that an entity in inventory has passed all phases of quality check that would ensure adherence to the regulatory standards

· To track and report to control systems, various phases of processing that the raw materials have passed which could formulate the proof of quality check

· To synchronously link up various systems like control systems, execution processes and production units.

· Facilitate compliance to 21 CFR Part 11 compliance with complete tracking, verification, and validation process

· Bring in precision in manufactured product tracking and genealogy by collecting historical information by referring to product ID, time stamp of manufacturing, production batch number, at each phase of manufacturing process, and across different manufacturing units. This will help automate reporting and labeling process as well.

· To track reusable assets and store details of the location and visibility of such assets

 Some critical Techno-functional steps involved in conceptualization and implementation of the solution are as under:

 · Blueprint a well thought out Technical architecture that weaves well with the existing infrastructure. More the deviation, more is pinch from investment and integration standpoint

· A lot of sub-systems will get affected in the process. Changes are rarely standalone and hence, middleware, wrapper applications, devices, ERP systems, reporting and control systems are to be integrated

· Budgetary plans need to incorporate support and maintenance of the system in an ongoing process that co-exists with rest of the IT infrastructure.

· This will affect the scope of regulatory assessment and audit. Hence SoPs, guidelines and custom thumb rules for RFID related processes is a must. A lot of documentation changes to the existing regulatory artifacts are inevitable.

Deploying RFID technology in Pharma manufacturing cannot adopt a big bang method. This involves a conscious assessment of impacts on various aspects, units and entities involved in manufacturing and the investment made on information systems presently. However, integration of the new information captured by RFID into existing systems needs to be a carefully thought approach and needs a lot of visibility into the adaptability of the same. Yet this can mean a better cost effective compliance, broader visualization of plant floor and information infrastructure that lead to minimized costs and uninterrupted production cycle.

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