Quality in biopharmaceutical manufacturing is non-negotiable. Especially in today's cultural environment, biopharmaceutical quality management plays a crucial role in safeguarding product quality and maintaining the reputation of biopharmaceuticals. Patients, healthcare workers, doctors, and consumers want companies to put safety and efficacy first and prefer products with proven records of these traits.
Besides the number of sales, biopharmaceutical quality management is crucial in mitigating risks. A quality-focused approach to manufacturing ensures that the most avoidable adverse events are prevented and unavoidable ones are dealt with swiftly.
Moreover, regulatory compliance is almost impossible without a proper quality management system. Major regulatory bodies, especially in the USA and EU countries, have tightened their requirements regarding QMS to ensure patient safety. The complex nature of the biopharmaceutical drugs adds to this issue.
Nowadays, people have become more aware of the quality of the products they consume; they consciously choose the product they want to associate with. Product quality also indicates a company's ethics, principles, and standards.
In this article, we will discuss how to navigate the regulatory aspect of biopharmaceutical quality management.
Top regulatory challenges in biopharmaceutical quality management
The regulatory field is challenging enough, even without the added complexity of biotech. However, when biotech and new inventions are added, it becomes even more complex. Here are some of the most common regulatory challenges faced by manufacturers of biopharmaceutical products.
Supply chain issues
Biotech drugs are unique in their compositions as they are created through different processes. Some biopharmaceutical drugs are also produced from cultured cells.
As defined by the ICH, raw materials are anything that comes into contact with products during manufacturing. Hence, anything from a pair of tweezers to packaging material can be considered raw material. To be compliant with safety regulations, each raw material needs to be assessed, including its source, composition, packaging, storage, the supplier's regulatory approval, etc.
Also, most companies source raw materials and equipment from suppliers. Since the manufacturing process is multiphased and complicated, listing the raw materials and ensuring supplier qualification is challenging.
Complex manufacturing process
The manufacturing process of biopharmaceutical products involves several highly sensitive techniques. While most manufacturing labs are equipped to maintain an ideal environment, ensuring quality and consistent results of these processes is a huge challenge.
Difficulty of definition
Biotech drugs are complex molecules. The manufacturing process has a lot of going on at the same time. Different components of the same process often require entirely different paperwork and submissions. Ensuring each component is covered is time-consuming and requires in-depth knowledge of regulatory obligations.
Recommended learning: Need a refresher on implementing a quality management system in research laboratories? This blog covers all the essentials you need to know!
Difficult data management
The complex manufacturing of biopharmaceuticals produces a lot of data. As regulatory bodies have tightened their data security and management requirements, manufacturers must sort, store, and analyze these data appropriately. For larger productions, the process is quite complex and poses a challenge to the regulatory team.
Composition complexity
Biotech products are still biologic products. Like most biological elements, these are also prone to variability. Even when produced under the exact same conditions, different batches of products may differ slightly. As such, ensuring consistent quality for biopharmaceutical products poses a regulatory and QA challenge.
Storage challenges
Biological products might also change during storage. Their components react to various environmental conditions like heat, cold, air, light, etc. For products that are more reactive or are stored for a long time, it is particularly complex to overcome this situation without changing the original composition to make it more stable.
Post-market surveillance
Regulatory compliance runs throughout the entire product lifetime. Post-market surveillance is equally important as pre-launch studies. However, it also adds extra complexity to the manufacturing of biopharmaceutical products.
Regulatory updates
Regulatory updates are a headache in every sector. However, they become especially cumbersome when the existing process is already complex. A huge part of biopharmaceutical quality management is keeping track of every regulatory change, small and large, and changing the technical data preparation and submission process accordingly.
Scilife tips: How to address regulatory challenges proactively in biopharma
Most regulatory challenges in biopharmaceuticals can be solved by ensuring product quality and smooth operation. Although there are many factors at play here, most companies leading the industry address these challenges by focusing on a smooth system that tackles it all: a quality management system.
A thorough, well-designed, and firmly implemented quality management system and a quality-focused environment address many issues before they arise. To get the most out of the system, it should be designed specifically to meet the unique needs of biotech manufacturing.
Ensure supplier qualification
One good technique is to practice supplier qualification assessment before starting manufacturing. It will save you a lot of headaches down the line, and all suppliers, including suppliers of raw materials and qualification assessment data, will be readily available for regulatory use as needed. Ensuring supplier qualification and reassessing them routinely will also reduce risks of quality issues with raw materials.
Use an eQMS
Using digital systems as much as possible saves your team time and effort. It will ensure smooth collaboration between teams and reduce clerical errors. Using an integrative eQMS like Scilife also allows teams to store data efficiently, seamless record-keeping, and continuous quality monitoring. An eQMS also eliminates prolonged preparation for internal audits and facilitates routine audits. It's a great tool for tracing the source of any issue, which comes in handy in any regulatory discrepancy.
Quality storage
Product distribution and storage are important, although often overlooked. To ensure product quality remains for a long time, establish a step in your QMS for assessing storage units and packaging before product storage. Take necessary steps to ensure quality.
Thorough inspection
Biopharmaceutical products are delicate and expensive. Producing a single batch can cost hundreds of dollars. Hence, redoing a faulty batch costs the manufacturer a lot of money. It also hinders regulatory approval. If there are too many reported adverse events, the product is less likely to get approved. A thorough inspection of all raw materials and strict quality maintenance can prevent both of these issues.
QMS and risk management
Regulatory approval is not a one-person job. No matter who is making the final submission, it always helps if everyone involved in manufacturing knows the regulatory standard for each process. This allows teams to keep track of key findings and documents and ensures all safety and performance issues are met before the product is launched.
Compliance team
Have a dedicated team that works only to ensure everything is going according to regulatory requirements. It doesn't have to be new hires; existing team members can also do it. However, having specific people responsible for individual tasks fosters quality awareness and establishes accountability.
Conclusion
Regulatory compliance is complex, but with the right strategies and tools, it can be manageable and smooth sailing. By proactively addressing common challenges, fostering a culture of quality, and implementing robust processes, biopharmaceutical companies can navigate regulatory requirements with confidence.
An integrated electronic Quality Management System (eQMS), like Scilife, can help you streamline data management, enhance collaboration, and ensure compliance with evolving regulations. As a result, your organization can spend more time focusing on what matters most- delivering safe, effective products while building trust and maintaining a stellar reputation.
