Navigating Stringent Regulations in the Pharmaceutical Industry: The Role of an Advanced WMS

The pharmaceutical sector operates under strict regulatory compliance and adhering to the guidelines of 21 CFR Part 11, GMP, DQSA, and GDPR is not only non-negotiable but critical to avoid reputation damage and costly fines. Both pharmaceutical manufacturers and distributors face exacting government and industry regulations, and have the pressure to store and distribute goods properly, while controlling the cost in order to survive in the competitive industry. Therefore, there emerges the need to embrace an advanced WMS (Warehouse Management System). 

Challenges in the Compliance:

1. Counterfeit and Substandard Medicine:

The World Health Organisation estimates that approximately 11% of all the medicines in the developed countries are counterfeit, contributing to around 1,44,000 additional deaths annually (European Pharmaceutical Review)​​ (UConn Today)​. Substandard medicines not only cost substantial amounts of money to the manufacturers but pose a serious threat to the consumer’s life. To adhere to the Falsified Medicines Directive (FMD), pharmacists have been required to scan the products to check their legitimacy.

2. Tracking and Serialization:

Guidelines from GS1 highlight five components of a serial number—Global Location Number (GLN) denoting country of origin, Global Trade Item Number (GTIN) to identify product type, Serial Number as a unique identifier for each product under the particular GTIN (SGTIN), lot information to identify batch, crucial for traceability and quality control and lastly expiration date to ensure product safety. To adhere to the U.S. Drug Supply Chain Security Act (DSCSA) and FDA’s Current Good Manufacturing Practices (cGMP), it’s critical to have the ability to track the products from manufacturers to the end user, thereby ensuring product authenticity and preventing counterfeit medicines. 

3. Temperature and Humidity Control:

Compliance with regards to temperature is crucial for preserving the pharmaceutical products. Each product varies with regards to storage conditions which brings additional warehouse complexities.  To ensure drug efficacy, the goods need to be maintained in certain conditions from the point of manufacture till the time it’s delivered.

4. Securing Documentation for Evolving Regulations:

 Regulatory bodies require detailed and accurate records of all the processes, from manufacturing to distribution. Maintaining the documents in the physical format can lead to errors and inconsistency. It’s also erroneous and prone to misplacement and tampering.   

How WMS Facilitates in Meeting Regulatory Compliance:

1. Barcode Integration:

Regulations with regards to U.S. Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD) mandates serialization to combat counterfeit drugs. Integration of Barcode in the WMS facilitates Lot and Batch tracking, enabling quick identification and isolation of products in case of quality issues, thus meeting regulatory standards. Companies can not only view how much stock is available based on batch numbers or expiry dates, and where it is located in the warehouse, but also provide audit trails for each item, giving full visibility into the onward supply chain. 

2. Temperature Monitoring:

According to IQVIA, approximately 90% of biologics and 60% of small molecules in the pharmaceutical pipeline require to be stored and transported in a certain temperature (IQVIA Healthcare)​​ (IQVIA Connect)​. A practical solution of WMS integrated with IOT sensors aids in monitoring and controlling these conditions in real time. Additionally, automated alerts notify warehouse managers in case of any deviations, ensuring that products are stored under optimal conditions. With traceability and visibility through the whole supply chain process, distributors can check that temperature tolerances have been adhered to, providing confidence in the integrity and viability of their products.

3. Expiry Date Management:

WMS keeps a track of the expiration date, ensuring that the older stock is used first before expiry using first-in-first out or first-expiry-first-out (FEFO) strategies. This prevents the distribution of expired or near-expiry products, thereby maintaining product quality and safety.

4. Document Digitization:

 A WMS digitalizes all records, converting all the physical documents into FDA required electronic format. A report by Mckinsey & Company states that digitalization in the pharmaceutical sector can lead to decrease in operational cost by 25-30% and approximately 25% improvement in efficiency (McKinsey & Company)​​ (McKinsey & Company)​.  

With the increasing supply chain complexities and stringent regulatory landscape, investing in an advanced and robust Warehouse Management System is not just beneficial but fundamental. 

An advanced and robust warehouse management system helps in improved supply chain management, optimize process, maximize savings, reduce inventory paperwork, real time visibility and tracking of inventory and ensure compliance.As regulations, especially in the US, continue to evolve, having a WMS that can adapt and meet these changing requirements will be crucial.