Secondary packaging is meant to protect medicinal products from production to distribution and utilization. Leaflets (instructions), blister cards, bobbin materials, standard and sticking labels, and other printing products are essential for preserving the quality of the finished product.
Secondary packaging, if it doesn’t meet established requirements, can give substantial grounds for withdrawal. That, accordingly, might have destructive consequences, directly affecting involved stakeholders, which include printing companies.
Printing houses providing services in the pharmaceutical segment must maintain supportive documentation that outlines order monitoring, material receipt and audit, packaging, distribution, and many other processes. But that comes with multiple challenges associated with manual record-keeping, which are typically causing incompleteness, inconsistency, error, duplication, and absence of information.
Printing houses directly related to the pharmaceutical industry must meet specific requirements and standards. In this short overview, we will dive deeper into the various challenges associated with regulatory compliance, and the potential benefits of introducing workflow automation.
The partnership with mature pharmaceutical organizations might bring significant opportunities and revenue. At the same time, strategic-thinking leaders must ensure that instructions, cardboard boxes, device packaging, and other printing materials are produced in accordance with multiple industry-specific standards.
The compliance with acknowledged regulatory requirements comes with considerable roadblocks and nuances. To avoid destructive consequences, responsible managers must ensure product identification and protection, branding, design, product sustainability, quality control, and other daily activities are being carefully monitored and performed.
By implementing business automation, printing companies might facilitate:
- Material replenishment
- Material receipt and audit
- Production control
- Quality control
- Product packaging
- Product shipping
To boost business performance, printing companies might apply:
End-to-end automation to monitor packaging production
The primary production stage, speaking about secondary packaging, is design, which has certain peculiarities. Getting down to design, the technicians must consider multiple parameters — the dosage of the finished drug, the degree of protection, the technique of filling and sterilization, and more.
The next production stages comprise prepress, printing, cutting, material folding and gluing, as well as control. Moving forward to the listed phases, assigned technicians should consider safety measures, which comprise tamper-evident and child-resistant design, antimicrobial packaging, holographic prints, braille font, and others.
There are various forms of packaging:
- Leaflets (instructions)
- Blister cards
- Bobbin materials
- Standard and self-adhesive labels
- Cardboard boxes
- Device packaging
And many important parameters to consider:
- Physical characteristics (shape, thickness, design, color, unit weight, tensile strength)
- Chemical composition
The first industry-specific challenge is the thought-out organization of processes, from design to distribution. That includes material replenishment, material receipt, material audit, production and quality control, subsequent packaging and shipping, and more.
The next, no less important challenge is the accurate maintenance of day-to-day supportive documentation. Data inconsistency might cause negative consequences — unjustified workloads, employee dissatisfaction, deficient performance, delayed time-to-market, and, respectively, reputational and financial damage.
To begin, we suggest printing companies to utilize management software to automate operational processes. With the right tools, printing factories might streamline internal communication and cooperation, and other important activities.
In addition, we advise business leaders to implement OCR technology to maintain supportive documentation. By re-thinking used routines, forward-thinking decision-makers might eliminate potential inconsistencies, respectively achieving regulatory compliance.
The concept in brief:
- A custom-designed management platform to automate operational processes
- With integrated optical character recognition technology to maintain supportive documentation
The functionality to include:
- Multi-tenant access
- Role-based access
- Workflow statuses
- Malfunction notifications
- Data extraction and processing
- Advanced analysis and reporting
Even well-organized printing houses are typically very inaccurate when maintaining supportive documentation. In general, assigned employees are handling mandatory records traditionally manually, causing impropriety. Given that, printing houses are facing the struggle to access and extract the requested supportive documents when receiving requests from pharma representatives conducting inspections to monitor control parameters. And at this point, incomplete, inconsistent mandatory records might cause serious issues.
That’s where optical character recognition technology helps process and maintain supportive documentation. The records can be still handled traditionally manually, and then be scanned, easily digitized and consolidated. With adopted handwritten text recognition technology, poorly organized paper piles can be finally forgotten. The record can be handled accurately, optimizing performance.
The concept is simple to explain:
- The records are handled traditionally manually and scanned right after
- The details are recognized, accurately processed, and transferred into the central database
- The system is configured to send immediate notifications under certain predefined conditions
- The manager is warned about any operational processes not meeting acceptance criteria
The solution can be trained to:
- Process documents with different, patchy layouts
- Recognize tables
- Process low-quality, hard-to-read documents
- Process offset, rotated documents
Starting their journey towards digital transformation, printing houses improve performance and profitability. And the business benefits do not end there.
For example, by implementing artificial intelligence, printing houses might introduce end-to-end automation. This streamlines day-to-day administration, accounting management, marketing and advertising management, logistics, distribution, and other integral parts of the supply chain, fraud detection, customer service, and more.
A custom-designed management platform might provide:
- Instantly accessible, accurate records
- Advanced analytics and reporting
- Up-to-date statuses
- Immediate notifications
Speaking about business benefits, that ensures:
- Reduced time and cost
- Increased performance, visibility, traceability, and profitability
- Waste control
- Regulatory compliance
The future lies in computational technology!