Pharmaceutical distributors and wholesalers are intermediaries between manufacturers and retailers:
- Ensuring timely, uninterrupted and secure delivery of finished pharmaceutical products
- Preventing influx of counterfeit pharmaceutical products
Pharmaceutical wholesale is an intricate process that comes with numerous industry-specific challenges. Overall quality, transportation conditions, temperature, humidity, appropriate sanitization, and other important factors must be carefully inspected and documented to achieve governmental compliance.
Wholesale distributors must meet regulatory requirements to ensure proper quality of the finished products. These requirements outline quality, transportation conditions, and storage.
To ensure proper quality, wholesale distributors must retain accurate documentation on every single process. But commonly, routine documentation is traditionally handled manually, which causes considerable issues.
Supportive documentation must be:
Control documents must be:
The issue: Colossal volumes notably hindering data management
Pharmaceutical distributors are facing grueling roadblocks when maintaining supporting documentation. Obligatory documentation includes records on shipment and arrival, temperature and humidity ranges, premise disinfection, and other essential factors.
To keep day-to-day documentation as required, pharmaceutical wholesalers must allocate notable resources. The traditionally handwritten documents increase risks, reduce accuracy and efficacy, and might even cause reputational and financial losses.
Among other critical factors, wholesale distributors must provide appropriately maintained:
Which has to be:
- Properly disinfected
- Necessarily maintained within required temperature and humidity limits
There are state laws by which pharma distributors in the United States and the European Union are guided. These specify ideal conditions for finished pharmaceutical products.
- USP <1083> Good Distribution Practices
- USP <1079> Good Storage And Shipping Practices
- USP <1118> Monitoring Devices — Time, Temperature, And Humidity
- FDA 21 CFR Part 203
- FDA 21 CFR Part 205
- Good Distribution Practices (GDP)
- European Pharmacopoeia, General notices
- Guideline on declaration of storage conditions for medicinal products particulars and active substances (CPMP/QWP/609/96 Rev. 2)
There are also acknowledged regulatory requirements (US, EU) associated with supporting documentation. These specify core principles outlining documentation for finished pharmaceutical products.
The solution: OCR technology to facilitate data management
We believe that adopting optical character recognition solutions notably benefits pharmaceutical distribution. This approach might provide multiple benefits such as reduced risks, increased performance and productivity, and more.
By adopting handwritten text recognition technology, pharmaceutical wholesalers might accelerate:
- Receipt control
- The condition of refrigerators
- The compliance with established temperature and humidity ranges
- The integrity of seals
- The presence of inappropriate or counterfeit pharmaceutical products
2. Quality control
- Product integrity
- External damage
- Serial numbers and marking
- Expirations dates
3. Storage control
4. Distribution control
Shelf life, demand forecasting, reverse distribution, and more
Wholesale distributors must ensure that finished pharmaceutical products have left at least one year shelf life, and can only ship medicinal products that have at least six months shelf life remaining before actual expiration. Some dispensers have even stricter requirements.
Wholesale distributors must control shelf life to ensure appropriate quality and provide end-consumer safety. But that can appear quite troublesome when maintaining paper-form records.
A custom-built OCR solution can automate manual routines:
- The product is scanned upon receipt
- The product’s expiration date is recognized and transferred into the central database
- The system is configured to send immediate notifications under certain predefined conditions
- The manager is notified about product’s, which are potentially or already unfit for distribution
What’s more, OCR technology can facilitate:
- Demand forecasting and replenishment
- Reverse distribution
Digitized records for optimized business operation
By adopting OCR and HTR solutions, pharmaceutical distributors might eliminate industry-specific challenges. These include human error, unconsolidated data, heavy workloads, dissatisfied staff, and other serious issues causing potential reputational and financial damage.
With implemented OCR or HTR technology, pharmaceutical wholesalers automate repeated manual routines. And having successfully resolved mentioned issues, strategic-thinking leaders can focus on their core goals.
Right tools provide for:
- Instantly accessible, accurate records
- Up-to-date reviews
- Simplified monitoring
- Advanced analytics and reporting
- Data digitization
- Data integrity and legitimacy
- Optimized inventory
- Optimized workflows, demand forecasting, reverse distribution, and replenishment
- Risk elimination
- Cost efficiency
Pharmaceutical distribution and wholesale, as well as other pharma subfields, come with various challenges. These include complicated assessment and management, data digitization, and compliance with acknowledged regulatory standards.
We believe pharmaceutical organizations can boost overall productivity by adopting advanced technology. Artificial intelligence, computer vision, in particular OCR and HTR technology, cloud computing, and blockchain can eliminate existing roadblocks and ensure optimized operation.
If combined with practices that ensure regulatory compliance:
- HIPAA compliance
- NCPDP standard Medical Claim Form Handling
- Good documentation practice
- Good distribution practice
Optical character recognition technology might streamline: