Compliance in the cold chain distribution of vaccines and other temperature sensitive pharmaceutical products is imperative. Pharmaceutical vaccines and medicines are vital to peoples’ survival. The environment is a huge biodiversity of germs, viruses, and microbiological forms. These organisms have the potential to either harm or benefit us. Medicines have been developed to help in combating the effects of these biologicals. Physicians are trained in choosing which medicines are appropriate for each is a specific disease. Each of those medicines must pass through rigorous testing before being released for patient use. Taking the wrong medicine could prove to be more harmful than the disease itself.
Compliance with the manufacturers recommended storage conditions must be strictly followed to prevent damage. Manufacturers and logistics providers must also adhere to the government’s pertinent regulations concerning cold chain supply delivery.
Companies have procedures, resources, and means to optimize quality and compliance with all regulations. Every stage of the cold chain supply is involved, not only the managers but also all the different parties monitoring the integrity and safety of the medical goods. Pharmaceutical companies are constantly worrying about the status of cold chain deliveries from the warehouse to the final destination. Adhering to procedures compliance by the logistics providers in the cold chain will ease quality anxieties of the company.
With ever-growing complexity in the global cold chain, however, there are continuing challenges to maintain compliance not only within company guidelines, but also within government regulations as well.
What are the challenges?
Data visibility should be constant throughout the entire cold chain, but with drug safety compliance, it is imperative. Clear transparency throughout the cold chain and 3PL operations help to stay updated on frequent regulation changes as well as preventing future excursions.
The biggest challenge across all aspects of the cold chain is the requirement for increased end-to-end visibility and transparency, covering temperature controls and traceability throughout the cold chain. Both concerns have clear implications for drug safety and compliance with regulations.
Regulation of the supply cold chain
Pharmaceutical owners of the vaccine cold chain have global regulatory requirements to observe while handling, storing, and distributing temperature-sensitive products to ensure the quality and effectiveness of the product. To ensure that shipping companies know the regulations, different regulatory bodies all over the world issue regulatory oversight documents for guidance. Several types of institutions issue such documents. Shippers must be familiar with updates from national regulatory agencies and international agencies, such as the International Air Transport Association, the International Conference on Harmonization, WHO, and the Parenteral Drug Association.
National regulatory agencies of other countries (e.g., USFDA, Health Canada, EMA) issue regulations for temperature control of drug products during storage and transportation. The increasing importance of pharmaceutical cold chain management has made major revisions in these guidelines, including from the United States Pharmacopeia, Health Canada, and the European Union.
The revised documents include the Good Storage and Distribution Practices for Drug Products, Monitoring Devices – Time, Temperature and Humidity, and the new Good Distribution Practices – Supply Chain Integrity in which the United States Pharmacopeia announced significant changes.
These documents, however, are mere “guidelines” in nature, giving the company room to set standards or determine courses of action. Although there is no obligation by law for the pharma industry to follow these guidelines, it is prudent for them to do so.
Five Insights for Compliance in the Pharma industry
The mix of regulatory compliance complexity and change can be challenging obstacles for pharmaceutical companies to hurdle.
Traditional compliance experts long ago thought that an insurance policy was enough to protect businesses against risk. The compliance landscape, however, is changing and it is time to take action.
1. Attaining the goal of company-wide involvement to reach compliance
Pharmaceutical companies usually managed compliance responsibilities by team or department. This might have worked for a limited period, but unfortunately, this isolated approach is no longer considered viable.
With today’s everchanging business models, compliance risk has become more connected and complex. This can be challenging for pharmaceutical companies because most of them do not have a full understanding of the compliance regulations and their responsibilities.
It is necessary to understand that the term “compliance” can mean different things to different departments, depending on the regulations involved. Assigning compliance to a variety of departments can make it difficult to meet the company’s responsibilities.
Some enterprises are determined to tackle this issue head-on. Mature pharma companies often establish “compliance committees” that support various areas of their business. The effectiveness of these committees, however, is still up for debate.
The fact is, companies need to be flexible in approaching different compliance solutions. There was a time when rules and regulations were not followed, making it easier for companies to ignore individual departments. That is no longer the case. Organizations need to take a serious, integrated approach to their compliance program. Fulfilling that goal is easier said than done.
2. Corporate compliance has a specific impact on global companies
The successes and failures of compliance programs depend on the resources dedicated to the project. A number of global companies have designated compliance officers in their main offices, but neglected to provide one in the smaller offices. Small business is most affected by the regulatory compliance revisions. If they won’t commit resources to all the offices, they run the risk of incurring penalties from government regulatory bodies.
There are two ways to avoid this risk:
- A center of “compliance excellence” is required where remote employees can ask advice from experienced compliance officers in the home office.
- Conduct compliance training programs for employees from smaller offices to improve understanding.
3. Ways to improve the efficacy of compliance solutions
Compliance examinations and audits can incur significant costs for pharmaceutical businesses.
The best option in reducing costs is by applying a continuing readiness model. This program enhances the effectiveness of compliance programs and prevents non-compliance.
Effective pharmaceutical companies prefer investing significantly in compliance programs over non-compliance is to avoid the possibility of excessive fees for fixing mistakes, incurring expensive fines, undermining brand equity, ruining reputations, or possibly incurring jail time for senior personnel.
4. Compliance that often overlooks Big Data, even though it is important
Pharmaceutical companies all over the world are focusing time and resources on Big Data, hoping it will reduce their compliance weaknesses. Using Big Data to run compliance programs can be a significant challenge.
Big Data, to most analysts, is a process that analyzes, and systematically extracts information from data sets that are too large or complex to be analyzed by traditional data-processing application software.
Two challenges blocking organizations from using data effectively:
- First Challenge: Using legacy systems to extract data for compliance documents can be frustrating. The systems are ill-equipped to collect and process accurate data for the compliance records while trying to observe new compliance regulations. The systems are not up to current specs on current regulatory demands
- Second Challenge: Absence of compliance reporting. Only 25 percent of reporting systems provide real-time compliance information, and only 19 percent of those systems can organize data according to detailed levels?
Many companies rely on manual reporting systems for their compliance documentation. This can be prone to errors and is not cost-effective. Manual reporting can result in costly damages to the business image. Capable reporting systems must be in place.
In order to manage compliance risk in the government ‘s dynamic regulatory changes, pharmaceutical companies need to have accessible records. The FDA and other regulators are broadening their scope of compliance requirements. In effect, they need to make regulatory compliance, and documentation of that compliance the center of their corporate strategy.
5. Regulatory change has a major effect on business innovation
Pharmaceutical companies work in an ever-changing business landscape. Customer expectations are evolving, and markets are thrown in disarray. Companies are in a quandary on how to set a rapid pace of innovation without losing their regulatory integrity. Balancing speed and accuracy is a constant challenge.
The US Food and Drug Administration, the European Medicines Agency, and other regulatory agencies are continually imposing regulatory changes that leave pharma organizations in a vulnerable position that can curtail their efforts to bring innovation to the field.
Thus, they are looking for ways to reconcile these two imperatives; investing in tools that will support innovation at scale, while still adhering to compliance standards and controls. Businesses are searching for processes that permit them to consolidate regulatory and business planning data, leverage automation and intelligence capabilities, and drive robust analysis of the impact of regulatory change.
Create a reliable solution for compliance
To comply with a Global Delivery Model (GDM) and Global Manufacturing Practices (GMP), as well as track and traceability regulations, such as the US Drug Supply Chain Security Act (DSCSA) and the European Union (EU) Falsified Medicines Directive (FMD), it is imperative that all of the personnel and organizations along the cold chain supply are also complying. Strict record-keeping, access to important data, thorough review, and a tight working relationship with people involved are all essential in ensuring compliance.
Having a reliable tool to monitor environmental conditions is critical. As the pharmaceutical supply chain moves from a cost center to a competitive edge, it is shifting more to digital. The days of cumbersome, manual PDF reports, and paper trails are being phased out as technology evolves. It is now more accessible than ever to implement IoT (Internet of Things) technology, combined with on-demand, cloud-based solutions, to augment supply chain data and share it with stakeholders.
Speed up shipment release time and manage by exception
Choosing a solution that is not only compliant, but that also offers real-time monitoring, adds value to the cold chain. Monitoring temperature-controlled products in real-time means that not all shipments need to be inspected before release. If alerts and notifications are sent at the moment temperature deviates, cold chain and quality professionals are notified that a shipment needs further investigation. This allows stakeholders to manage by exception, and only check those shipments where something wrong occurs. In addition, receiving shipment data in real-time increases the opportunity for corrective actions before pharmaceutical products are damaged.
Having accumulated data on spoilage in your possession adds even more transparency, as that data can also be shared with logistics partners and freight forwarders. Providing these stakeholders with reliable data builds trust with business partners as well as patients, improving both brand image and business relationships. Maintaining this data in-house also eliminates reliance on third-party stakeholders for accurate cold chain data.
In the end, real-time data can be used to better predict when, where, and how temperature deviations occur. This enables pharmaceutical manufacturers to control cold chain risk and bring continuous improvement. It not only increases ROI, but it can help lower insurance costs, save time, and increase company presence in the market.
Sharing cold chain data with stakeholders
No matter if the company is a CMO, a distributor, wholesaler, warehouse, or a pharmacy cold chain, it is expected that the company can ensure that products at each step of the cold chain are kept safe and secure. Being able to expedite and easily report on cold chain data, and share it with the stakeholders, is important to promoting transparency and achieving end-to-end visibility.
Adding location data to the report increases this visibility and provides insights into who is responsible for the products at the time and place a deviation occurs. It allows a quick reaction to prevent damages, as well as to identify immediately the root causes of the problems, allowing for future preventive actions.
As regulatory changes continue to be issued, the pharmaceutical industry as a whole must adapt and evolve while maintaining steadily innovative strategies to meet the demands of patients across the world. This is a good time for pharma companies to upgrade their compliance structures to enhance the broader interests of the organization.
Companies should always find new opportunities to invest in compliance functions that cover multiple business areas such as regulatory policy changes, cold chain, and data management.