The pharmaceutical business is a highly regulated industry due to the nature of diverse and complex products, which directly impact patients' health. Supply chain logistics play a crucial role in the transportation and storage of pharmaceutical products, many of which require specialized temperature conditions until they reach patients.
Hence, inventory management is critical and faces some challenges, such as
1. Regulatory Compliance
Pharmaceutical companies operate under stringent regulatory bodies like CDSCO, USFDA, EMA, etc. Regulatory compliance is a mandatory protocol, and failure to comply can result in product recalls, hefty fines, and even company closure.
One of the major challenges is the traceability of the pharmaceutical products. Traceability is of utmost critical in supply chain management failure to achieve it may lead to financial losses and penalties imposed by regulatory agencies.
2. Product Expiry Management
Pharmaceutical products or medicines could be potentially toxic to patients if used beyond their expiry date. Hence, it is imperative for pharma companies to have a system in place to track the expiry dates effectively, manage product recalls and ensure patient safety.
3. Temperature Monitoring
Medicinal products like vaccines and biologics are temperature-sensitive and require controlled temperature conditions during transportation and storage. Failure to comply with temperature storage or cold chain logistics requirements would lead to loss of the product's viability, compromise its safety and efficacy, and consequently result in economic losses for the companies.
Poor inventory management can affect the supply chain in numerous ways:
1. Financial Losses to the Pharma Companies
When the demand and supply of products are misaligned, it can lead to overstocking or understocking, resulting in increased warehouse costs and the risk of product expiry. This can cause companies to lose significant amounts of money if not addressed with the right solution.
2. Cost of Non-Compliance and Damage to Brand Reputation
When expiry products are not traced within the system, it can lead to wastage of these medicines. If the products are not traceable in terms of their expiration or storage conditions, it can cause product degradation due to the failure to maintain proper storage conditions.
Similarly, recalling a defective batch will also become challenging if it cannot be traced by the system. This can create regulatory non-compliance issues, leading to hefty fines, and may generate a negative sentiment among healthcare professionals and patients about the brand.
The risk of losing the trust of the healthcare community can damage companies financially and
socially.
3. Risking Patient Care
Poor inventory management can lead to overstocking of the expired products or shortage of crucial medicines, which can potentially impact patient's healthcare.
How to Be Compliant with Inventory Management and Profitable at the Same Time?
1. Invest in trusted Inventory Automation Software
Inventory Management software specifically designed for the pharmaceutical industry can be a powerful tool for maintaining compliance with regulatory bodies. The system should include features like real-time tracking, proper batch control, third-party integrations, and readily available reports to ensure adherence to regulatory guidelines.
Keacyte is an AI-powered Inventory Management software that addresses inventory challenges with its unique features, including:
2. Tracing Expiry Products and Recalling
Expired or recalled stocks can account for 10-12% of total monthly sales of medicines. Keacyte offers AI powered tracking of products inventory and expiry across geographies. Its early alert system for expiring or recalled products helps reduce waste and minimize financial losses. It provides real-time insights into supply shifts, production planning, and CFA stock allocation, streamlining expiry and inventory data across the pharmaceutical distribution chain.
3. ERP Integrations
Its third-party integrations with leading ERP systems create an open exchange for sharing data between operators and companies.
4. Inventory Audit
Monitoring the movement of goods in real-time optimizes inventory costs and addresses stocking issues. It ensures a true sales data audit for accurate brand and regional performance tracking.
5. Reports
Tracking and auditing your sales across geography becomes easy with Keacyte. The report's insight helps in managing the inventory and strategizing the supply.
6. Regulatory Compliance
Complying with regulatory bodies for inventory management processes is essential that includes the maintenance of records, audits, and proper documentation for the movement of goods. Regulatory compliance will ensure that inventory is properly managed with adherence to guidelines, thereby avoiding penalties from regulatory authorities.
7. Audits and training
Regular audits will help identify shortcomings in the inventory management process, and rectification will aid in complying with regulatory bodies. Regular training also ensures that staff is well-equipped with inventory management procedures and regulatory requirements.
If inventory challenges are addressed properly with effective strategies, pharmaceutical companies can minimize waste, improve profitability, and also enhance compliance with regulatory bodies. Furthermore, the adoption of advanced and integrated software solutions, such as Keacyte, can play a pivotal role in significantly simplifying the complexities of Pharma Supply Chain Management. Pharma companies can ensure inventory accuracy, regulatory adherence, and sustained profitability with Keacyte.