Three Best Practices for Warehouse Monitoring

Published by Ariel Arcebido on

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Three best practices for warehouse monitoring will be explored in this article. Protect your cold storage from temperature excursions. Warehouses are an important part of the pharmaceutical cold chain. They are the intermediate storage locations for vaccines and medicines prior to delivery to the final destinations. Patients depend on receiving quality medications that have been properly stored. People tend to think that the warehouse sector is a “cut-and-dried” business— that it’s all about installing shelves in a big empty room and putting goods on those shelves—but warehouses are much more than that. 

Warehousing isn’t just about storing goods. A lot can go wrong if improper storage is employed, especially for pharmaceutical products. Medical products can easily spoil if the warehouse temperatures are not within the required parameters.

Comprehensive, precise temperature monitoring systems are needed for warehouses storing pharmaceutical goods, to ensure the safety of the products. Failure to adhere to guidelines on cold chain temperature monitoring can lead to inventory losses, potential lawsuits, and bankruptcy.

Cold Chain

Warehouses storing medical products require special attention and must be designed to maintain storage conditions prescribed on the manufacturer’s label.  Specifically, they should be clean, dry and maintained within the prescribed temperature and humidity limits.  These should be regularly monitored and recorded.  

Typical prescribed practices for the storage areas and facilities:

  • Pharmaceutical products are to be placed off the ground and spaced to allow cleaning and inspection.
  • Pallets should be kept clean and in good condition. 
  • Storage areas also must be clean, and free from debris and vermin.  A written log should be maintained to indicate the method and frequency of cleaning, and the type and use of pest control. Pest control chemicals should be safe from contaminating the medical goods and emergency procedures must be setup to prevent accidental spillage. Clean up procedures must be established, in case of spillage.
  • Receiving and dispatch areas must have shelter structures to protect medical products from the weather. Reception zones should be equipped with cleaning materials for the pharmaceutical products before they enter the storage areas. 
  • Separate quarantine rooms must be constructed for sensitive biological products. The quarantine rooms must be clearly marked, allowing entry only to authorized personnel to ensure the integrity of the product from outside contamination.
  • A separate sampling area within a controlled environment is required for testing the medical materials. If the sampling is to be conducted in the storage area, it should be in a location designed to prevent contamination or cross-contamination.  
  • A waste holding facility must be added for the storage of rejected, expired, and recalled materials or products. The waste materials and products areas must be clearly marked. Waste materials may include highly reactive and radioactive materials, narcotics, sensitive materials, and pharmaceutical products. Combustible liquids, solids, pressurized canisters and other materials at special risk of abuse, fire or explosion must be treated with special attention. Appropriate additional safety and security equipment must be placed in the waste area, in the event of an accident.
  • The storage of waste narcotics materials should be in compliance with international conventions, as well as national laws and regulations. The rejected medical materials are to be placed in a quarantine facility until procedures are taken to dispose of them.
  • To ensure accuracy and safety, adequate lighting must be provided wherever storage activities are to be conducted. 
  • It is best that temperature monitors be located in areas most likely to show erratic temperature fluctuations. Temperature mapping will show temperatures across the warehouse facility, to insure consistency. To maintain the accuracy of the monitoring system, regular calibration is a must.
  • Storage conditions for pharmaceutical products and materials should be in compliance with the labelling, regularly monitored through stability testing.

Storage requirements documentation: 

  • Written instructions and records must be readily available that document all activities in the facilities areas, including the disposal of expired stock. A detailed description of storage and shipping procedures that identifies the products and their destinations is required.
  • Permanent information, written or computerized, must be present for each stored material or product, showing recommended storage conditions, any special instructions to be observed, and retest dates. Pharmaceutical protocols and updated national regulations concerning labels and containers should be followed at all times.
  • Records should be kept for each delivery. These include the description of the goods, quality, quantity, supplier, supplier’s batch number, the date of receipt, assigned batch number and the expiration date.  These records should be stored for a period equal to the shelf-life of the materials and products, where applicable, plus one year, according to national regulations.  
  • Complete records should be available showing all receipts and issues of materials and pharmaceutical products according to a specified system, (e.g., by batch number).
  • Materials and pharmaceutical products should be stored in safe containers which protect the quality of the products from external exposure, bacterial and humidity contamination.
  • The containers should be clearly labelled identifying the name of the material, batch number, the expiration date, storage instructions and reference to the pharmacopoeia, where applicable.   
  • Upon receipt of incoming materials and pharmaceutical products, each incoming delivery should be matched against the relevant purchase order and each container physically verified by the label description, batch number, type of material or pharmaceutical product and quantity.
  • Delivery labels should be examined for uniformity of the containers and, if necessary, should be separated by the supplier’s batch number in case the delivery is more than just one batch.
  • Every container should be inspected carefully for possible contamination, tampering and damage. Suspicious containers, or even the entire delivery, must be isolated for further examination if anomalies are detected.
  • To ensure safety, samples should be taken only by adequately trained and qualified personnel and in strict accordance with prescribed instructions. Containers from which samples have been taken must be clearly labelled accordingly.
  • Once sampled, the goods will be quarantined. Batch separation will be enacted during quarantine and all subsequent storage. These products will remain in quarantine until an authorized release or rejection is issued.
  • Pharmaceutical products cannot be used once rejected. They are stored separately from other materials and pharmaceutical products while awaiting disposal or return to the supplier.

Stock rotation and control:

  • Periodic stock rotation should be done by comparing the actual and recorded stocks. Any significant stock anomalies should be checked against accidental mix-ups and/or incorrect issue.
  • In production facilities, partially used containers of pharmaceutical products should be securely reclosed and resealed to prevent contamination during restorage.  Before using unopened containers, the partially used containers must be used up first.
  • Damaged containers should be disposed of, unless the material or products are unaffected. The person in charge of quality control must be notified and the damage documented. 
  • Identifying outdated and ineffective materials and pharmaceutical products:
  • All products must be checked with regular frequency for ineffective and outdated materials. This ensures that these materials are not circulated or sold. 
  • In the case of returned goods, they should be properly documented and handled in accordance with approved procedures.
  • All returned goods should be stored separately and returned to the place of origin. If the returned stock is re-evaluated by a qualified person, it can re-distributed with documentation concerning the re-issue, and labeled accordingly. If the product was returned by a patient, it should be destroyed promptly.

Dispatch and transport

methods fo transportation for logistics
  • Transport of the goods must be followed in accordance with procedures such that their integrity is not compromised and storage conditions are met.
  • Special handling should be exercised when using dry ice in cold chains. The dry ice must not be in direct contact with the product, to prevent quality degradation.
  • The use of monitoring devices is a must in the transportation of temperature sensitive materials. Monitoring records must be available for examination.
  • The dispatch of pharmaceutical products should be done only after receipt of a delivery order. The receipt of the delivery order is mandatory documentation. Dispatch protocols are followed and documented, including the nature of the materials and pharmaceutical products concerned and any special precautions required.
  • The container should offer adequate protection from outside contaminations and should be clearly labelled.
  • Records for dispatch should be preserved, stating at least: 
  • Date of dispatch; customer’s name and address; product description (e.g.,  name, dosage form and strength, batch number and quantity; transport and storage conditions).
  • In case of a product recall, there must be a procedure for recalling defective pharmaceutical products and materials from the market promptly and effectively.

To achieve appropriate warehouse monitoring there are three best criteria to observe: 

1. Security

Due to the value of vaccines and other biological products on the black market, it’s imperative for warehouses to have good security systems. Warehouses, however, commonly come up short. Millions of dollars’ worth of pharmaceutical merchandise is stored in large spaces with only a few employees looking after it. In most cases of theft, the thief turns out to be one of the employees.

While warehouses are a tempting location for thefts, trucks are the most vulnerable. Holiday weekends are the most preferred days for thieves to strike. 

To reduce the occurrence of theft, as well as improving the ability to respond quickly and catch the thieves, the following practices must be implemented:

Install Security Systems. Choose the latest digital, cloud-enabled security cameras with powerful resolution and contrast with multi-function for both dark- and bright-light conditions. Cameras must be monitoring for 24/7 and cover all possible blind spots. Cameras in prominent places will help deter thieves from pursuing their goals.

Institute automated and remote-access lockdown procedures. Motion detectors during off-hours can alarm the chosen security force of illegal entry, allowing you to alert law enforcement while it is still in progress.

Install Barriers. Barriers on the property’s perimeter can be a deterrent for would-be thieves. High fences and controlled gates can force the thieves to abort their plans. The cover of darkness cannot help them avoid well placed cameras and motion capture devices.

Employee background checks. Scanning every employee’s history can root out security concerns. Insurer Hiscox estimated that 68% of workplace thefts are committed by employees.

2. Data Management

Warehouses are massive and anyone can get lost in their numerous spaces. Without adequate data management, finding where all the products are stored in the labyrinthian corridors can be frustrating. 

Use a reputable data management model and adhere to its program. The best models use automation-friendly, cloud-enabled databases to merge with other systems. 

Data storage software should be FDA 21 CFR Part 11 compliant.

FDA 21 CFR Part 11 Compliance

Best practices for warehouse data management include:

Logical Data Model. Otherwise known as Logical Schema, this model can be applied to any group or subgroup of input data. Whatever category system you choose, make it constant across all data management processes for the warehouse.

Give Objects Codenames. This includes data, columns, rows, relations between columns and rows, and entire databases. Use recognizable names if possible. If code names are necessary, make sure key stakeholders can understand the code.

Use Unique Usernames for Each Recognized User. Avoid sharing usernames. Changes in the database need to be traced back to the source of the change, for the data to have integrity.

Establish a Standard for Granting Database Privileges. Hand out privileged credentials by seniority, longevity, proven trustworthiness, or other considered measures to determine which users are trustworthy with the privileges. 

Exclusivity in Supervisor Privileges. Abuse of supervisor privileges is very real. Choose carefully those who are worthy of that privilege.

3. Environmental Monitoring

Merchandise stored in the warehouse is prone to extremes in temperature, pressure, and humidity. Whole shipments can be ruined by failure to observe environmental conditions.

When storing sensitive pharmaceuticals products or vaccines, warehouse owners and managers must pay special attention to environmental monitoring. 

Best practices for environmental monitoring include:

vaccine temperature monitoring
  • Thermal Mapping. In large warehouses or facilities, temperatures can vary wildly from one side of the facility to the next, in to seasonal changes in extreme climates.
  • Warehouses storing temperature-sensitive materials should have “thermal mapping” plans which take temperature readings at critical positions within the facility—near exits, in the corners, at floor level, at roof level, etc. Thermal mapping should also occur during extreme weather or seasonal changes.
  • Effective thermal mapping can identify locations within the warehouse that tend to be hotter or colder than other areas, highlighting them for needed adjustments in HVAC calibration or construction.
  • The use of Cloud-Enabled Data Loggers. This is especially important to regulated industries such as the pharma industry. A comprehensive system of monitoring conditions with expert data loggers and secure data storage form an important part of warehouse management.
  • Digital data loggers use a variety of sensors such as thermometers, pressure sensors, or barometers to measure ambient conditions around the facility. A computer chip analyzes the measurements, and inputs the measurements to a built-in data stick. Data loggers offer automation, and improved accuracy, as well as greater data gathering than hand-recorded measurements.
  • An even more efficient technology exists in the wireless-enabled data loggers that input the data directly to cloud storage, where it can be analyzed by artificial intelligence and automatically generate reports for the warehouse manager and the regulatory agencies for verification of compliant conditions.

Conclusion:

With the effects of the present pandemic, medical supply warehouses have important roles in the cold chain supply that delivers anti-Covid 19 vaccines to the health care centers around the world. 


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