How a Life Sciences Total Quality Strategy Can Address Obstacles
For modern life sciences companies, quality management efforts often top the list of challenges they face when working to bring new products to market. Today’s highly competitive environment favors fast release cycles, while mergers and acquisitions have resulted in large organizations that span the globe and that are more difficult to oversee. Additional regulatory scrutiny has also increased the compliance burden. Between December 2010 and January 2013 alone, the FDA issued 1600 warning letters to pharmaceutical companies.1 To further complicate matters, disparate quality processes make collaboration and communication between departments difficult and often lead to redundant data and information. Firms may attempt to address these issues on a case-by-case basis, their efforts are prone to failure when a total quality strategy is not in place.
An Effective Quality Strategy Focuses on More than Operational Issues
One of the first places people look when trying to answer questions about quality is the operational chain. The creation of therapeutics has quality compliance risks. Are raw materials of the right quality? Are produced batches adequately tested and what was the outcome? Have all activities been recorded and properly documented? Can the integrity of quality data and documentation be guaranteed? These are only a few of the quality-related questions asked during the operational process.
Quality strategies that focus on operations do so for good reason. Looking at the warnings issued by the FDA between 2010 and 2013, we can see that pharmaceutical companies consistently lapsed in similar areas. For example, many life sciences companies did not maintain satisfactory control over raw ingredients and suppliers. Incoming materials may not have been properly documented, ranging from improper labeling to failing to test for acceptable quality. Companies may adopt a chemical management system to address these problems. However, for some firms, implementing such software in isolation may ultimately add to more overhead and release cycle inefficiencies if newly assumed tools do not take the firm’s overall quality strategy into account.
An effective quality strategy complements the company’s corporate plans from start to finish. Rather than focusing on quality at merely the operational and manufacturing levels, life sciences companies should ensure that measures are already in place at the research and development phase and continue on through the release cycle until the end. This means that research used to develop new products needs to consider aspects to avoid compliance risk at a later stage. If the founding research is faulty, how can a life sciences company guarantee that the resulting product won’t cause complications in patients six months down the road?
An Effective Quality Strategy Unifies Multiple Systems
One of the reasons ineffective quality management systems persist is the perspective that different departments are responsible for their own quality issues due to separate operational goals and aims. The reality couldn’t be further from the truth. While ensuring the quality of facilities and equipment may seem separate from production quality, the two areas are tightly interconnected. High-quality products cannot be manufactured without facilities and equipment that pass quality standards. Quality of materials includes confirming that received ingredients are satisfactory, as well as making sure that only ingredients from trusted vendors are acquired in the first place.2
The goal of a total quality strategy that unifies a company’s quality management system with its corporate plan is to eliminate the idea that separate areas work in isolation. The department in charge of manufacturing a new drug may pass their quality standards but their efforts will amount to nothing if the ingredients used originate from a faulty supplier. The product will still fail pre-release quality controls.
When different areas use disparate systems, there can be a lag time between when someone notes a deficiency to when knowledge of that deficiency reaches the affected team. On the other hand, an effective system connects different departments with the aim to ensure quality earlier. Imagine being able to immediately notify a supply chain that one of their ingredients doesn’t meet quality standards. They can work to rectify the situation then and there. It’s better to address anticipated quality issues earlier in the release cycle than after a product has been made available on the market, which can severely impact a company not only in terms of increased scrutiny on the part of regulatory agencies but also in terms of lost business, trust and opportunity.3
As the market grows increasingly crowded, life sciences companies will need to find ways to retain their competitive advantage. One of the best ways to do so is by developing high-quality, innovative products and releasing them to market faster. Unfortunately, maintaining quality can be costly and slow down the release cycle due to disparate and disconnected systems and when organization mainly focus on compliance only. And rather than treating quality as the responsibility of a single department, firms need to implement a total quality strategy that links different areas together for the purpose of improving quality at the earliest possible opportunity. To learn how implementing a total quality strategy can benefit your life sciences company, please request our survey report or contact us today to ask about BIOVIA Total Quality.
- “Recent Quality Issues in Pharmaceutical Compliance: Lessons from Warning Letters,” May 22, 2013, http://www.pharmoutsourcing.com/Featured-Articles/137533-Recent-Quality-Issues-in-Pharmaceutical-Compliance-Lessons-from-Warning-Letters/ ↩
- “The Six Subsystems of a Pharmaceutical Quality System,” March 20, 2013, http://www.pharmacompliancemonitor.com/the-six-subsystems-of-a-pharmaceutical-quality-system/4585/ ↩
- “Costs of Failure in Product Quality,” April 2, 2012, http://www.pharmacompliancemonitor.com/the-six-subsystems-of-a-pharmaceutical-quality-system/4585/ ↩