Summary
Warehouse Managers across industries have a tough job due to the very nature of their tasks, the amount of value (funds, profits, employees) that are under their responsibility, and the constant security that needs to be maintained.
The same challenges are greatly amplified in the Pharmaceutical and Healthcare industry since the government closely mandates and monitors the production, storage, and movement of its items.
What are the challenges faced by Warehouse Managers?
Warehouse Management has come under increasing pressure in recent times due to the burgeoning growth of Ecommerce and Online firms. The massive Fulfillment Centres of today are areas of the vast scope of work and excellence but are also faced with constant challenges to maintain high levels of efficiency.
Some issues that Warehouse Managers constantly grapple with include:
- Inventory management (reorder levels, supply-chain, packing, loading, dispatching)
- Maintaining requisite temperatures (varies according to sections) for temperature-sensitive products (e.g. perishables, medicines)
- Maintaining security for goods, intellectual property, employees
- Maintaining mandated procedures and regulations for the handling of goods
What are some warehouse management challenges in the Pharmaceutical industry?
Just like all other warehouse management challenges, the pharmaceutical industry also grapples with several such. While many of these issues exist across industries, they become amplified with the pharmaceutical industry due to the sensitive nature of its products, its impact on people’s health, and the (often) emergency situations under which they are pressed into use. There are also several issues that are specific to the pharmaceutical industry:
- Temperature: Manufactured drugs, precursor chemicals, and active pharmaceutical ingredients require stringent temperature control. Typically, storage temperatures range between 15-25°C (59-77°F). Specific product categories (e.g. vaccines, medicines containing hormones) often need freezing during storage as well as transportation. Failure to maintain such drugs within their specified temperature controls not only reduces its efficacy but could also cause changes in their chemical composition
- Humidity: Moisture is a huge problem in maintaining the effectiveness of a medicine. For example, if blood glucose strips are exposed to moisture, it would result in inaccurate readings
- Exposure to light: Often, the chemical composition of medicines can undergo a change upon prolonged exposure to light from the sun (ultraviolet rays). Photodecomposition, post-drug administration side-effects (e.g. photoallergy, phototoxicity) are other harmful effects that have been observed
What is the “Current Good Manufacturing Process”?
The FDA (Food and Drug Administration) mandates a “Current Good Manufacturing Process” (CGMP) to establish the requisite standard for drug storage and warehouses management processes. These include:
- Storage: detailed guidelines outlining the conditions under which each drug is to be stored
- Tracking: maintaining careful track of all product categories and their prescribed storage and handling protocol within the warehouse
- Contamination: careful cleaning and inspection while in storage
- Unique identification: all drugs must be identified and stored with their unique codes that can be easily identified and traced. Related data such as batch size, receipt (etc.) must also be maintained
- Handling and distribution: Detailed guidelines outlining the process of handling and distribution for each product (recalls to be carefully outlined too)
What are the rules of “Good Manufacturing Process (GMP)”?
Remember that, while all Warehouse Managers face pressure at their task, those in the pharmaceutical industry have to also constantly deal with government scrutiny due to the nature of the industry.
However, upon following the rules of the “Good Manufacturing Process” (GMP) manufacturers can:
- Ensure safe storage for medicines as well as raw materials
- Ensure against decomposition and degradation of finished products
- Ensure that expired products or damaged goods aren’t mistakenly shipped out
- Prevent product or material contamination
For example, the following types of items that feature on the packaging bill of materials require a lot of unique identification numbers and are governed by procedures outlined by the GMP.
- Printed materials, packing materials, precursor chemicals, APIs
Maintaining the correct documentation for these is always a challenge for Warehouse Managers.
1) Storage: Defective products are often a result of poor storage procedures and inadequate control over material movement within the warehouse. Warehouse best-practices mandate that:
- Similar product-types are should be stored accordingly
- Unique codes are visible
- Correct labeling with updated and accurate information (e.g. expired, damaged, ready-for-shipment (etc.)
- Material movement within the warehouse is tracked minutely right through to the point that they are shipped out
- Addictive drugs and toxins are stored appropriately. Access is given only to approved personnel
- Ideally, samples that are not for sale, counterfeit ingredients and materials, damaged, returned, and recalled goods to be stored separately
- Finished goods, unused goods are quarantined till shipped out
2) Testing: Stringent requirements for sampling rooms must be maintained as mandated by the authorities e.g. clean instruments, PPE kits, positive-negative air pressure to create secure airlocks and prevent contamination
3) Shipments: GMPs mandate that materials be reviewed per its use. Starting chemicals must be scrutinized. Additionally:
- Stored safely, and according to prescribed storage methods
- Its supply source must be approved
- Be registered in the firm’s database of approved inventory items
- Display correct labels with the requisite information
- Must be damage-free, defect-free
- Be “quarantined” till all quality-control checks are completed
4) Tags and labels: GMP rules are very clear about maintaining the correct labels on products and materials. They must include its standard name and its UIN (Unique Identification Number) and this must be separate from the one assigned by its supplier.
Expiry dates, barcode trackers, color codes, products under investigation, rejected items, approved items, finished goods ready for release, quarantined items (etc.) are just some details that are captured via effective labeling
5) Using technology: As is the case with all industries, unless your technology and systems are updated to modern-day methods, you would certainly operate at a tremendous disadvantage. Often, you will probably be on the wrong side of the mandated legal procedures for the same. Deploying automated software, cloud technology, mobile devices, latest hardware (etc.) is an absolute must.
6) Security: Pharmaceutical products, drugs, and their various components are always liable for theft simply due to their high costs. Additionally, such products always have high demand, thereby further increasing their attraction for theft.
Therefore, safety protocol for warehouses within the pharmaceutical industry needs to be much more stringent. Required procedures and measures must be adopted at all the stages of production, MIS creation, data systems protected against malicious access, tampering of data prevented, stringent audits and scrutiny measures put in place, and best practices implemented for modern-day threats like cybercrimes.
Conclusion: Due to the sensitive nature of its products, Warehouses Managers in the pharmaceutical industry have to tackle issues that are absent in other industries, including following the stringent regulations as mandated by the FDA.
Deploying effective software like modern warehouse management software as well as using logistics companies that use the best last mile delivery software to manage their deliveries is the way to go.
