Pharmaceutical products are essential to life on Earth. Unfortunately, they are quite fragile and there are many regulations surrounding how they should be stored. The importance of These best practices as part of correct pharma compliance have come to the forefront amidst the COVID-19 pandemic. The vaccines have to be kept at very specific temperatures to ensure their survival.
All stages of the pharma compliance process need to be carefully monitored through a powerful quality assurance program, so the end products are fit for their purpose. This is why the industry is so carefully monitored by multiple organizations.
The Governance Of Pharma Compliance
Legislation governs how quickly pharma companies can bring a product to market, as well as how such products should be stored. There are huge fines for non-compliance, meaning pharma companies have to be extra diligent when following procedures. These fines can also be damaging to the reputation of the company.
Major organizations that enforce compliance on pharma companies include the FDA, DHHS, EMEA, and VA. Most companies in this industry are also subject to SEC rules stemming from the Sarbanes-Oxley legislation, which relates to reporting and control.
In addition to the rules and regulations that pharma companies must adhere to, there are many other best practices companies follow. While not legally enforceable, they can increase efficiency and make pharma compliance standards easier to meet.
Pharma Compliance Best Practices
Good Distribution Practices (GDP) are key to pharma compliance best practices. Vaccines are known as “cold-chain” products, meaning they need to be kept at low temperatures during both storage and transit. If the temperature goes above or beyond a certain range, the product will spoil. These GDP guidelines were created by the World Health Organization and are meant to be followed by all involved in the storage and distribution of pharmaceutical items. The guidelines also extend beyond vaccines.
Other guidelines include those the Current Good Manufacturing Processes (CGMP), which is listed by the Food and Drug Administration (FDA). This is the main standard for consumable products and is often seen on various health items. These guidelines are flexible but encourage the use of a quality control system to prevent errors and contamination. This sort of quality assurance is critical in the pharmaceutical industry, where minor errors can lead to catastrophes.
The USP Good Distribution Practices is another series of guidelines. This organization has a global reach and offers critical technical assistance to developing countries. The purpose of this series of guidelines is to create a “set of recommended practices for helping to ensure supply chain integrity for drug components (drug substances and excipients) and drug products (medicines).”
Additional Information For Safe Pharma Compliance Storage
All guidelines and best practices recommend a strong quality management system to monitor the creation, storage, and distribution of sensitive healthcare items. For safe and effective pharma storage compliance, the infrastructure needs to have sufficient space, be able to withstand adverse weather conditions, and be thermally efficient and easily cleaned. Sanitization and pest control also need to be included in this program, needing to be well-thought-out because, unlike other manufacturing items, you cannot simply pile vaccines on top of one another. If there is no space, another facility needs to be found. There must be separate, clearly designated spaces for contaminated, recalled, approved, rejected, long- and short-term storage, and other categories.
The refrigerator and freezer units need to be carefully assessed before purchase. These may also need regular maintenance and will need to be replaced well before they run the risk of malfunctioning. These units also need a backup power supply in case of power outages, which can ruin an entire batch.
The new era of interconnected products and services will also have implications for pharma storage. It will mean that an item is continuously monitored on the supply chain, with information automatically uploaded and recorded throughout the lifecycle. Integrated analytics will help to ensure vaccine safety from start to finish.
Data Logging For Pharmaceutical Products
According to Dickson Data, pharma compliance is imperative for the modern era. This compliance is best achieved through the use of automated data loggers, which do essential work by logging temperature data. Temperature needs to be continually monitored, with alerts for when the temperature leaves a certain range. Data loggers and temperature sensors can also be used when products are in transit. There should always be an automated system in place where information is automatically recorded. In this way, whenever anything is out of alignment, an alert is generated and can be acted upon immediately.
The Future Of Pharma Storage Compliance
The future of pharma compliance will heavily involve sophisticated sensors and web applications that make it more or less automated. If all information is continuously recorded, it will mean that any errors can be detected and rectified before getting out of hand. This can help pharma companies meet many standards set in place by various agencies. The practices, guidelines, and laws relating to pharma storage are most certainly needed, as the end result could be severe health problems for consumers. Increases and improvements in technology could hold the key to safe and cost-effective pharma storage, compliance, and distribution.