The importance of the role of lab management and quality management in life sciences cannot be overstated. It’s the backbone of ensuring medicines are produced safely and effectively, directly impacting patient safety. It’s the very core of GMP. However, it’s not without its challenges. The necessary quality control processes involved, can cause unavoidable delays that can ripple through the supply chain.
Before raw materials can be used in production, they must be tested and approved. Finished products also need rigorous testing before they can reach patients. In fact, testing also includes sampling of water and the analysis of bacterial cultures in cleanrooms. It is not solely about the material flow itself but also about the facilities, utilities, and equipment utilized in the process.
While this testing throughput time is usually accounted for in the production planning, unforeseen delays in quality control often affect the production chain. And… the longer the quality control process, the longer it takes to sell the product to customers, resulting in delays across multiple departments – from sales to logistics.
3 bottlenecks in batch release
1.Prioritizing
One of the major bottlenecks in lab management is the complexity and time required for batch releases. Not every batch holds the same priority. A batch with sufficient stock has less urgency compared to a critical product that needs to be delivered to a customer. However, labs do not always have clear insight into these priorities.
2.Pooling of tests
Another challenge is the pooling of tests, where the lab waits to process multiple batches at once to maximize efficiency. This can be beneficial in some cases, but it is always a balancing act. This is especially true when it concerns samples that need to be processed with urgency but are forced to wait due to this practice.
3.Manual lab work
Additionally, the reliance on manual processes and paper-based documentation in many labs slows the entire operations down. Analysis results are often recorded on paper, manually entered into systems, and subsequently reviewed. This not only consumes a lot of time but also increases the risk of human error.
The impact of these inefficiencies on the supply chain is significant. Extended release times create delays in the overall supply chain, leading to higher inventory levels, higher costs, and, in extreme cases, risks associated with product expiration dates. In worst-case scenarios, products are released, only to reach a warehouse with limited remaining shelf life or even nearing their expiration date, creating risks for waste and financial losses, further complication distribution.