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September 7, 2020

Pharmaceutical product labeling is a highly regulated process and plays a significant role in driving product approvals and maintaining data quality and safety. Each labeling leaflet includes important product information such as the brand /drug name, manufacturer name and address, batch /lot number, product description details, active and inactive ingredients, indications, safety information, usage instructions, storage conditions, and expiration date.

The pharmaceutical labels are not just an important way to make customers aware of the specific formulations of a product, but also to protect them from incorrect usage of the formulations. 

A product available in any geographical market requires its labels to comply with the country/region-specific regulatory requirements. Such variations in regulatory requirements for the same product across the globe increase the risk of having inconsistent information across labels. It is believed that roughly 50% of pharmaceutical recalls are due to product labeling or packaging artwork errors. Therefore, to avoid recalls and ensure product success, companies must inspect the artwork at every step of production and ensure that the most recent approved information is released to the market. 

Pitfalls of Mislabeling a Pharmaceutical Product

  • Compromising Patient Safety: Any errors in labeling could lead to the misuse of a drug and cause side effects, sometimes leading to death.

  • Incurring Fines/Recalling Costs: Recalling a product due to a labeling error is an expensive affair and can hurt the company's financials.

  • Crossing Paths with the FDA: The FDA has set clear guidelines on pharmaceutical packaging. If a manufacturer fails to comply, the FDA is well within its right to recall the product.

  • Wasting Valuable Time: Investigating the case of a labelling error and finding subsequent resolution of the same consumes a lot of time that can be avoided with better vigilance.

  • Blow to Company's Reputation: Recalling a product is usually done in public purview and hence can cast a negative impact on a company's image. 

How Technology Can Change the Pharmaceutical Packaging Scenario

Just like in plenty of other sectors, technology plays a pivotal role in driving innovation in the labeling environment, too. Due to recent advancements in analytics and intelligent automation, pharmaceutical labeling and packaging is evolving rapidly. Organizations are now leveraging automated labeling processes to reduce cycle time and costs while ensuring consistency, accuracy, and quality in labeling.

How Covid-19 Has Paved the Way for Automation Technologies in Drug Packaging Scenario

The Covid-19 pandemic has seen organizations increase its focus on operational resilience, agility, and transparency through the greater deployment of automation technologies. For any business to grow and sustain in the long run, it is crucial to gain end-user confidence. With the pandemic introducing lockdown restrictions and social distancing norms, intelligent and active labeling is the best approach to combat the situation and steer the business forward. 

In the existing COVID-19 environment, all stakeholders expect to have minimal product contact and gain customized information through new and improved digital experiences. These expectations are only bound to increase. So, digitizing drug product labeling information can help pharma companies improve customer experience and end-user compliance.

Technology automation can transform label content management and label operations, enabling pharma labeling teams to enhance their productivity and efficiency. A few potential areas where technology can disrupt the traditional labeling process and enable faster approvals include:

Content Management Automation

  • Label quality control automation

  • Smart regulatory intelligence automation for global and country-specific requirements 

  • Company Core Data Sheet (CCDS) creation and upgrade through automation

  • End-to-end labeling automation [e.g., CCDS create and update, summary of product characteristics (SmPC)/United States Prescribing Information (USPI) create and update]

  • Local label creation from CCDS automation

  • Local label life cycle management and translation 

  • Label tracking for compliance through automation

Global Labeling Automation

  • Parallel comparison of labels

  • Compliance checks for label deviations

  • Set rules or controls for alerts on deviations

Digitization of Labeling Leaflet

  • Providing QR codes on the product labels

Adoption of label automation techniques provides many benefits, including reduced process complexities, lower personal dependencies, and cost savings. As a result, organizations obtain faster approvals and, in turn, drugs reach the end-users faster. 

The Way Forward

The COVID-19 pandemic has been a watershed moment for pharmaceutical companies engaged in the traditional process of drug labeling. Labels should provide the end-user with everything they need to know about the product, enabling them to make a fully informed decision about what is a safe and appropriate choice during the pandemic and beyond. It is quite clear that regulatory process automation will soon replace the current practice and act as a catalyst for accelerating label submissions and expediting product approval processes.


Vijaya Kumar is working with the Advanced Drug Development (ADD) platforms and CMC & Regulatory Operations team as a domain consultant with Chemistry, Manufacturing and Controls as core expertise. He is a registered pharmacist with a degree of M. Pharmacy in Clinical Pharmacy and carries a vast experience of more than 16 years in Regulatory Research & Development,  Regulatory Chemistry, Manufacturing and Controls, and strategies for USA, Canada, EU filings. He has authored both international and national publications in clinical and community pharmacy.



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