Outsourcing The key factors
The increasing threat of counterfeit drugs is placing a huge burden on the pharmaceutical industry, and the assignment of a unique serial number to each product on the market is an important preventative measure. According to data published earlier in the year from the Pharmaceutical Security Institute, nearly 6,000 pharmaceutical crime incidents were reported to the organisation in 2021 – 38% more than the year before and the highest figure in almost 20 years. In low- and middle-income countries, the counterfeit threat is even greater, with the WHO estimating 10% of medical products circulating in these regions are counterfeit. “One key process that is critical for drug processes is the ability to aggregate units to cases accurately, creating serialised relationships in the packaging,” explains Mager. Many regulations, such as the Drug Supply Chain Security Act (DSCSA) in the United States and the Falsified Medicines Directive (FMD) in the European Union, mandate accurate serialisation and aggregation to enhance patient safety and combat counterfeit drugs.
Of course, serialisation is just one of many ways to combat this issue, but it remains a crucial factor to consider when picking the right manufacturing partner. For Viraj Gandhi, CEO at Medivant Healthcare, one of preeminent concerns should always relate to the end result of the manufacturing process – the quality of the drug. “Quality control and assurance are paramount when drug companies are evaluating contract manufactures,” Gandhi says.
Given that its end users are patients, maintaining the highest quality standards is paramount in the pharmaceutical industry. Contract manufacturers must have robust quality control systems in place to ensure consistency and safety in their products. Cost efficiency also needs to be at the forefront when making the decision, however, it’s essential to strike the balance between this and product quality. As well as cost, geographical location plays a crucial role in the decision-making process. The choice between local and international manufacturers can affect logistics, supply chain efficiency, and the ability to manage and oversee production. If a company does decide to go with an overseas manufacturer, they need to weigh the pros and cons before making an informed decision. Other key factors that play an important role include capacity, communication, and suitability with product areas. Many pharmaceutical companies also place an emphasis on the environmental impact of their operations and how contract manufactures are able to address this.
Reputation matters
In the wake of the Covid-19 pandemic, reliance on contract manufacturing has increased significantly, which has highlighted several flaws in their systems.
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As such, checking the reputation of the manufacturer has become a crucial part of the process. “In particular, the ability for a packaging organisation to produce compliant products for each market is critical,” Mager says. “Drug shortages have occurred due to package operations failures.” A study conducted by the University of Utah Drug Information Service found that ongoing and active drug shortages are at the highest they’ve been in a decade. While this may not be entirely due to operations failures, ensuring that you’ve partnered with a reputable contract manufacturer is one simple step companies can take to guarantee their product meets demand.
Serialising drug products using appropriate labelling and supporting technology can help prevent counterfeits entering the market.
“Maintaining proper controls and documentation for all materials, equipment, and processes provides critical assurance of quality standards.”
Viraj Gandhi
Other potential issues that could arise by choosing a partner with a poor reputation include the potential for recalls and patient safety being put at risk. One way to find out the reputation of a manufacturer is by assessing their compliance with current Good Manufacturing Practices (GMP) regulations, a baseline requirement for contract manufacturers. A lot of the time, quality control is a built-in part of the manufacturing process. But ensuring a manufacturer complies with GMP is a critical step to protecting the reputation of a pharmaceutical company and its products.
“Companies will audit facilities, examine training records, and review manufacturing back records to verify GMP adherence,” says Gandhi. “Maintaining proper controls and documentation for all materials, equipment, and processes provides critical assurance of quality standards.”
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