06 November 2018 210

Improve regulatory compliance with a strategic, enterprisewide labelling approach

Pharmaceutical companies are recognizing more and more that labelling is a critical mechanism for maintaining compliance, improving operational efficiency, and supporting business growth.

In a world as complex and regulated as pharmaceuticals, labelling must be viewed from a strategic, systemic perspective

Without a strategic approach, a pharmaceutical company is likely to experience:

  • Excessive Regulatory Costs - Pharma companies must comply with specific regulatory requirements in each market where their products are sold. Failure to rapidly respond to regulatory changes results in supply disruptions, lost revenue, and customs fines.
  • Inefficient Access to Critical Data - Packaging labels are often created using disparate processes that maintain off-line data sources (often relying on manual data entry or the use of individual productivity tools such as spreadsheets). The resulting errors, redundancies, inefficiencies, and mislabeling can significantly impact patient safety.
  • Local Labelling Inefficiencies - In the past, label processes were driven locally. While local operators were able to comply with regional requirements, the variety of labelling solutions and systems lacked accuracy and were operationally inefficient.
  • Inconsistent Branding - Disparate labelling processes make it challenging to apply branding guidelines and standards to globally manufactured and distributed products in a consistent manner. This can result in lost sales, increased regulatory scrutiny, and delayed entry into new markets.

By treating labelling as a strategic process, and by implementing an enterprise labelling solution (standardized and centralized), pharmaceutical companies are able to

  • reduce regulatory costs,
  • eliminate data redundancy,
  • improve overall labelling efficiencies, and
  • achieve consistent branding.

A true enterprise labelling solution enables operators to perform their value-added tasks without having to access separate labelling systems or worry about keeping labelling synchronized with process or operational data. It enables companies to apply business rules to operational data, in order to automatically determine the right label format, content, and device based on the context of the business transaction.

This approach enables pharmaceutical companies to rapidly respond to changing regional and international regulatory requirements and provides a new level of visibility and control to validated label management.

READ THE FULL ARTICLE (SOURCE: Pharmaceutical online).

How can we at CMAST help?

CMAST provides Regulatory compliance and quality services and can help you implement an enterprise labelling solution. Our Regulatory Experts and Project Managers have experience in labelling compliance programs & optimization projects; and the portfolio management thereof. They are involved in artwork activities, share their knowledge through the CMAST Regulatory Center of Excellence and are able to support with Business and IT solutions.​

Sofie De Keersmaecker, Project Manager

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