The sudden need for ambient products to meet GDP standards necessitates the implementation of controlled-room-temperature (CRT) technology to previously exempt product lines. For many manufacturers, this means heavy costs. Alejandro Rosado García Cano, quality assurance head at Novo Nordisk, tells us how a different mindset can help in this scenario.
Research breakthroughs in products aimed at alleviating ailments progress hand-in-hand with the requirements to help maintain the molecule’s stability. This usually has a direct impact on operation costs, and constitutes a major compliance challenge for those involved in the manufacturing and distribution processes.
Health regulation agencies, the pharmaceutical industry, wholesalers or distributors, and patients’ first points of contact, such as pharmacies and hospitals, have the responsibility and moral duty to comply with the product’s conservation requirements along the supply chain to ensure the medicine’s efficiency.
In recent years, the handling of cold chain products (those that require refrigeration) has become tightly regulated across the pharma supply chain. And now, industry quality managers are paying close attention to CRT products. Historically, CRT products could be shipped with standard packaging, but such medicines are now receiving specialised services similar to those of cold chain medicines – geared to the temperature ranges listed on the product label.
The logistics and quality departments are responsible for the successful implementation of control mechanisms aimed at complying with temperature conservation requirements. The more these teams work together, the more efficient performance will be. Therefore, it is essential to develop open channels of communication as well as define key responsibilities for those participating along the supply chain.
The phrases ‘quality culture’ and ‘quality mindset’ have been around since the 1990s. Even though much debate has happened in the past ten to 15 years, there’s still widespread concern among companies and professionals as to what it really means, how it can be achieved and what its purpose is.
To correctly implement CRT technology, it’s crucial to educate staff about the greater purpose of what they do, how their decisions impact the business and the quality of the drugs. The personnel that make up the quality department should view themselves as tools to achieve the company’s objectives in an appropriately sequenced manner, based on their contributions, guidance, and ability to face and overcome challenges. They must leave behind the old-fashioned idea that the quality department is an internal control or auditing area, that was once seen as a major obstacle for the implementation of new ideas and innovative ways of doing things.
Staff must be aware that they are responsible for maintaining the balance between complying with requirements and response capacity. As experts, this means that when it comes to regulatory, corporate and product requirements, it is their duty to comprehensively understand internal procedures and interact with the departments involved, to guide decision-making with a cost-benefit approach and consider target dates.
It is imperative that staff recognise and assess the risks involved in day-to-day operations and how those risks can be reduced in different scenarios. Employees in the pharmaceutical industry must accept and embrace their roles in a strategic area of the sector, providing solutions compliant with regulations, based on flexible models that can be adapted dynamically. They must consider and assess operational aspects, pay attention to the needs of internal clients and identify benefits that can be obtained by implementing key performance indicators (KPIs).
Choosing a supplier
A commonly adopted model across the sector is to engage the services of a supplier to undertake complete and integrated operations, or to outsource key parts of the operation to an experienced supplier that has the know-how and resources to fulfil the task. Storage and distribution companies are examples of this increasingly common practice within the industry. Choosing the right supplier is a precondition to have successful operations – that’s why, in most cases, companies assemble a multidisciplinary team comprising of at least one staff member from corporate security, one from operations (logistics and distribution) and one from the sales department.
There’s an old saying that goes: "Your business is only as strong as your suppliers." But there is a stark difference from one country to another in the range of available suppliers that design and construct temperature-controlled rooms for product storage, or that develop qualified temperature-controlled transports for distribution. Unfortunately, this is a problem of availability of resources, and investments made by small or local companies from developing countries, represent a major challenge compared with global companies or TNCs, which have greater financial support.
Usually, the internal requirements from TNCs, as stated in their corporate procedures and policies, surpass those set by local regulations, as they were developed and consolidated from requirements set by the strictest health authorities globally.
When choosing a strategy that necessitates developing a supplier, the quality department must communicate the importance of fulfilling internal requirements, and maintain status and reputation. Furthermore, it needs to design and develop the working plan with the supplier, agreeing and committing to each step and stage required to reach the goals defined by the company. The supplier tends to commit to improving and enhancing its response capacity, because its personnel has endorsed and embraced the company’s working philosophy.
To achieve optimal results, the company and its supplier must share a common purpose and understand how they both can benefit from the relationship.
The contracting party must make its goals and requirements clear to the supplier so that all the finances, personnel and time invested in the project ensure that the final product will meet operational, quality, regulatory and cost requirements. The supplier’s responsibility is to build its capacities while meeting the client’s needs, as this will strengthen its operations and quality control systems. This will give it a competitive advantage and help integrate itself into the local, regional and global supply chain.
Another quality concept that has been around for several years is the continuous improvement of processes, products, services and systems. But how can efficiency levels of services be achieved to consider them as an in-control or living system? It is simple – this is the responsibility of the quality department working to the mandate of the entire organisation.
Managers must find the way to foster personnel’s operational excellence and avoid getting stuck in the staid, by-the-book approach. This will empower managers and their staff to search for simpler and more efficient ways to get results with the best operational procedures, policies and directives.
Empowerment, however, must be based on a capacity-building/capacity-updating programme that lets staff know the corporate and regulatory requirements, and helps them to understand that their success directly impacts the patients’ health and security.
For large companies, or those growing in size, it would be a terrible mistake not to maintain awareness of environment, market and competitors. Supply chains are motivated by the needs of a client or consumer, and in this industry, by the needs of a patient.
The main purpose of us working in the supply chain and cold chain, regardless of the department we belong to, is to deliver the end product whenever and wherever the patient requires.
This is why the working schemes of pharmaceutical companies are preventative. This means that they undertake continuous analysis to meet internal needs (compliance with corporate and product requirements), to solve a problem efficiently and in line with the companies’ economic objectives – and without jeopardising the product’s quality.
In my experience as quality department leader, I have had the opportunity to play a key role as an interpreter in the company’s departments. I try to understand the importance of meeting operative KPIs, and match them with the products’ requirements for proper conservation during the storage and transportation stages. The main objective, as always, is to ensure the product’s quality to guarantee the patients’ health and integrity.
I was able to do this because I have had an unparalleled opportunity to know, in detail, how the warehouse floor operates and how inventory is managed. I understand quality concepts, such as best practice for documentation, equipment qualification, critical control points and process, and area validation.
To properly achieve a quality culture, all interested parties need to understand the nature of the products being handled. It is important that they are aware of the impact of handling, storing and transporting the products within the temperature and humidity ranges required, because the benefit or harm of complying, or not complying, with the requirements will be felt most acutely by the patient.