Good Pharmaceutical Storage Monitoring And Best Practices
Pharmaceutical drugs are fragile and, at the same time, very crucial to our survival. These drugs tend to be susceptible to time and temperature changes. When exposed to the wrong environment, these drugs may be rendered ineffective. This is why everyone in the industry is responsible for ensuring the drugs’ strength and quality are maintained throughout pharmaceutical storage monitoring.
Why Is It Important?
Good distribution practices are essential in the maintenance of drug safety and quality across the supply chain. The Good Distribution Practices (GDP) Compliance lists the best practices for pharmaceutical distribution. However, maintaining the quality of medicines throughout the supply chain is challenging. The indicated shelf life and storage conditions are the main factors that contribute to the challenges of the pharmaceutical supply chain. The various dosage forms like injectables, syrups, and tablets need to be transferred and kept under different environmental conditions. A general handling practice will not be suitable for all medicines, so there are specific requirements for handling each of the dosage forms.
Cold chain products, such as vaccines, are often stored at a temperature between 2 to 8°C. Due to this, cold chain staff should take extra precautions to avoid product failures. The GDP guidelines were established and intended to be followed by all people and outlets who are involved in the process of storage and distribution of pharmaceutical products.
FDA Current Good Manufacturing Practices (CGMP)
The Food and Drug Administration is the one who implements and oversees the Current Good Manufacturing Practices (CGMP). The CGMP is the FDA’s main regulatory standard for pharmaceuticals intended for human consumption.
The FDA is responsible for pharmaceutical storage monitoring compliance with CGMP’s requirements regarding the methods and facilities used throughout the drug manufacturing, processing, packing, and distribution. Compliance with the regulations ensures that the strength and integrity of the drugs are maintained. This is made possible by mandating concerned pharmaceutical supply chain stakeholders to adjust their operations accordingly.
The best pharmaceutical practices begin with a quality management system. This prevents contamination, deviation, mix-ups, and errors. The establishment of formal controls ensures that the drug products adhere to FDA standards.
Since these regulations are flexible, it allows companies to utilize new technologies and innovative methodologies to achieve better quality through continuous improvement. The C in CGMP stands for “current” to encourage stakeholders to use up-to-date pharmaceutical storage monitoring equipment.
The U.S. Pharmacopeia is highly involved in the pharmaceutical Good Distribution Practices. It has a global reach, containing offices in Switzerland, Ghana, China, India, Ethiopia, and Brazil. This allows them to extend global assistance on laboratory quality control, pharmaceutical training, and intercepting low-quality medicines from being released to the public. They also provide crucial technical assistance to developing countries.
The USP GDP includes all people and organizations involved in pharmaceutical storage and distribution, from the acceptance of raw materials at the plant during manufacturing to the final shipment of the finished products to the consumer.
Some of the key stakeholders of USP GDP include laboratory operations, manufacturers, importers and exporters, transport distribution companies, third-party logistics providers, importers and exporters, retail pharmacies, and healthcare offices.
Quality Management Systems (QMS)
The Quality Management System (QMS) is the foundation of an effective GDP program. A proactive QMS has several sub-systems for minimizing risk, documentation, transport, storage ad temperature. The QMS serves as the framework of GDP. Built on the foundation of the FDA’s CGMP, it should be customized to the organization’s specific requirements. If a company does not adhere to a structure, it will put the entire supply chain at risk.
Storage Management System
In order to start with a storage management system, companies need to have the necessary storage location and ensure that adequate controls are set up. These locations usually involve buildings and facilities used for drug storage like warehouses, hold areas, contractor warehouses, distribution areas, retail pharmacy areas, and pharmacy storage areas.
Two processes usually occur in these buildings and warehouses.
First – Receiving and transferring. Receiving means bringing a product into the storage location while transferring is moving a product, whether internally inside the facility or out of a vehicle.
Second – Storing and holding is the temporary possession of a drug. In this process, no movement of the product is done.
Drug storage facilities are instructed to follow specific orders and guidelines before operating. These guidelines are according to the storage requirements of the products. Most pharmaceuticals needed to maintain the temperature indicated on their labels. Also, the facilities must have sufficient space for their intended usage to prevent overcrowding. These facilities should be designed to withstand environmental conditions when needed, and they should also be composed of materials that are easily cleaned. The sanitation and pest control procedures should also be laid out within the required frequency of cleaning and the materials used to do so. While implementing pest- control programs, it is important to ensure that contamination does not occur.
The necessary storage areas should be organized. The approved, rejected, quarantined, recalled, and returned product should be clearly segregated. Computerized systems used for storage control conditions should be thoroughly checked if they are performing according to their intended purpose. Facilities should have integrated controls to mitigate potential environmental hazards such as fire, water, or explosion. Specific products can trigger these kinds of reactions and should be properly stored. If storage areas are not computerized, they should be labeled with the appropriate visuals.
Pharmaceutical storage monitoring devices or systems are also required for close and remote monitoring. Maintaining the temperature in critical facilities is not just an 8 to 5 job. It’s a 24/7 job for all key people in the facility. Minimal changes in temperature might affect the potency of a product.
Drug Product Mobilization
Drug product storage also involves the time it spends held at the receiving bay area. Upon arrival at the warehouse loading docks, they should be promptly transferred to the designated storage area within a specific time period to minimize the risk and exposure of a product. Furthermore, this will ensure that it spends minimal time outside of the specified storage conditions as described in the procedure.
Drug product reactions to ambient conditions often occur quickly. This is why receiving docks should ensure that the drug product deliveries are protected from inclement weather. Likewise, storage areas for loading and unloading docks for receipt of drug products should be kept clean and free from pests.
Only authorized persons should have access to the incoming receiving area. The delivery vehicles/containers should be inspected thoroughly before the products are unloaded to ensure that the integrity of the products was maintained and free from contamination during transit.
Refrigerators and freezers
The drug product should be stored appropriately in the refrigerators and freezers that can accommodate the temperature it requires, as indicated in the label. A refrigerator unit is often set to 5° C with an allowable range of ±3°C for products that require to be stored at 2°–8° C. Meanwhile, freezer temperatures often range from 25°C to −10°C. Some frozen drug products need to be stored in much lower temperatures like dry ice or liquid nitrogen temperatures.
The drug products should be stored in the units in a way that allows adequate airflow. This will ensure that the specified conditions are maintained. Freezer and refrigerator units should also be located in the facility in a way that they are not subject to extreme environmental conditions. If it is unavoidable, stakeholders must ensure that the mapping protocol includes a provision for testing in case of environmental extremes.
Walk-in cold rooms and other large commercial units should be qualified through temperature mapping to determine if the unit is suitable for storing the drug products. Temperature-recording devices should be used to record temperatures and provide the necessary temperature maps. Afterward, the units should be monitored accordingly as per the results of the mapping.
Distribution Processes and Packaging
Primary, secondary, and tertiary packaging should be used in order to protect the drugs during storage and distribution. As part of the manufacturer’s QMS, package performance testing should be conducted.
In order to evaluate package performance, test procedures for factors compression, shock, vibration, pressure, and other transit events should be conducted. Modification or removal of the original packaging may expose the product to improper conditions. Unnecessary package tampering should always be avoided.
The packaging for the distribution of the drug product should be carefully selected and tested in order to ensure that the product quality is maintained. This will also protect the content during distribution against possible environmental or physical damage.
Warm and cold packs should be used inside transportation containers to control temperature conditions properly. Barrier protection is also important in determining the material positions since it avoids direct contact with the drug products. It is also important to know if using dry ice and its vapors would not negatively affect the drug product, including its label.
AKCP Wireless Temperature Sensors
Place the NIST calibrated, certified temperature sensor with internal calibration check and failover on your shipment, inside your warehouse or medical refrigerator. Monitor temperature and log data internally. Anytime the sensor is within range of an AKCP Wireless Tunnel™ Gateway (WTG) data is synchronized and uploaded to AKCPro Pharma-Mon Server.
The sensors are suitable for use in any situation when the accuracy and reliability of the data are imperative. Typical usage would be in pharmaceuticals where the monitoring of temperature in medical refrigerators, vaccines, and temperature-sensitive drugs is critical. AKCP has dedicated sensors designed for the pharmaceutical industry with glycol jar attachment for the sensor to comply with industry best practices
There are several guidelines and practices that should be followed in order to ensure that a drug product’s integrity is maintained throughout the pharmaceutical supply chain process. It is important that these measures are consistently applied at every step since mishandling can permanently cause the drug to lose its potency. Since drugs are often temperature-sensitive, the temperature should be properly monitored at all times to avoid excursion.