Avoid adverse regulatory action with comprehensive quality

Attention to detail is par for the course within most modern industries and fields, including scientific research. In addition to finding ways to remain competitive in today’s crowded market and maintaining margins in the face of rising R&D costs, life science organisations must also consider regulatory oversight from federal agencies. Regulatory agencies are increasingly holding sponsor companies responsible for quality standards followed at contract organisations.

In 2022, the US FDA issued multiple recalls — more than 130 recalls to temperature abuse, 100 caused by products stored outside appropriate temperature conditions, and 51 associated with manufacturing using a contaminated excipient that had already been recalled by its supplier¹. No matter the area, the message is clear: life science quality management is the top priority and is everyone’s responsibility.

The Drug Supply Chain Security Act (DSCSA) was established in 2013 as a crucial regulatory framework providing the FDA with oversight of the pharmaceutical compounding industry, as a result of lapses at a facility that had resulted in fatal consequences. A facility’s reputation can be irrevocably damaged due to poor life science quality management, leading to firms suffering from a tarnished image caused by a loss of public faith. The Act also protects the integrity of the pharmaceutical supply chain in the United States, with an overarching objective to prevent the diversion and counterfeiting of drug products.

Life science quality management is a continuous process

Given the magnitude of the circumstances leading to the passage of the DSCSA, it would be expected that other compounding facilities would be more vigilant — but this is not the case. The number of Form 483s issued by the FDA, indicating observed conditions or practices in a facility that violate FDA’s requirements, has increased steadily over the years — from 215 in 2021 to 466 in 2022 and 510 in 2023². This shows that inspections at the facilities of organisations remain crucial and continue to reveal multiple violations despite regulatory frameworks in place. While no adverse health effects are necessarily associated with these facilities, the findings (which include microbial contamination and lack of environmental monitoring) lead to negative associations that can easily undermine public confidence.

Increased regulatory oversight puts additional pressure on organisations, but it is proper life science quality management that supports the development and manufacturing of quality products. The reality is that high standards and adherence to protocols can minimise compliance risks. This can be achieved by adopting an automated quality management system with continuous feedback to support timely improvements by flagging any deviations from acceptable limits. This in turn would alert the relevant departments that corrective action is immediately required, acting earlier in the release cycle rather than at the end.

Digital solutions can ease the burden of life science quality management

Maintaining high life science quality management can be a serious investment for many organisations. Quality procedures already make up a signification portion of overhead and can require more resources than firms may anticipate. This could explain why federal agencies are still finding companies lacking on multiple fronts, such as lacking documented procedures to guarantee drug quality or a failure to follow up on out-of-specification results. Inefficient organisational procedures are no excuse and regulatory agencies have demonstrated that companies will be held accountable, even if the offending facility is in another country or a collaborating firm.

To remain compliant while maintaining high quality, organisations stand to benefit greatly from finding ways to streamline their quality management processes. This doesn’t simply mean adopting an automated system to assess quality in each department. The biopharma landscape is increasingly complex, with dynamic regulations, skilled labour shortages, higher demand for personalised medicine and increased competition. Adopting digital solutions like a controlled document management system could greatly help companies by ensuring accurate information throughout the entire product development life cycle.

With controlled document management, organisations can enjoy improved regulatory compliance, version control, document security, electronic signatures and compliance, audit readiness, efficiency and productivity, and product quality. A streamlined process that enhances workflow efficiency goes a long way in ensuring product safety and adherence to quality standards.

At the broader level, a single application available to all key stakeholders involved in quality management can make continuous improvement more manageable. Innovations like the BIOVIA Biopharma Quality Management Analyst Solution can help to bridge this gap by granting easy access to all records and offering analysis capabilities for comprehensive quality management. Implementing digital tools can be a reasonable solution to tackle problems faced, but disjointed adoption can lead to more inefficiency and problems. Rather than disparate processes that can overlap or even be redundant, organisations should strive to implement an integrated solution that supports the maintenance of high-quality standards and meets regulatory compliance in a harmonised manner from start to finish.

From ensuring that materials used onsite are of high quality to strict adherence to quality protocols, the right set of processes can enable efforts to release quality products and avoid adverse regulatory action. Learn how you can streamline all quality-relevant processes in your organisation with a comprehensive life science quality management solution that ensures quality and compliance throughout the entire product life cycle by integration, automation and harmonisation — ultimately helping you maintain quality in the face of rising regulatory oversight.

_{1. FDA (2022), Fiscal Year 2022 Report on the State of Pharmaceutical Quality}

_{2. FDA (2023), Inspection Observations}

Image credit: iStock.com/Thanakorn Lappattaranan