The manufacture of safe and effective pharmaceutical drugs and therapeutic agents is critical to human health and well-being. To ensure patient safety when consuming these products, it is essential for all pharmaceutical quality control (QC) labs to undergo thorough testing of raw materials and products in accordance with relevant guidelines and regulations.
The accelerated production of new drugs and therapeutic agents necessitates the implementation of effective QC measures to improve the quality, performance, and safety of products and reduce the risk of costly errors and recalls. With greater demands for faster time to market, there is increasing pressure for QC labs to achieve more with fewer resources. However, this is particularly difficult under circumstances of higher staff turnover, mounting sample complexities, and a relentless drive to reduce risks and errors.
Implementing QC at Increased Speeds – Major Challenges
To keep up with growing demands to increase their speed of operations, modern QC labs face a number of challenges, including:
- reducing errors that may cause lab downtime and inefficiency;
- mitigating risks during method migration and transfer;
- reducing instrument downtime;
- streamlining asset management for greater productivity; and
- supporting compliance and data integrity.
Common human errors, due to untrained or inexperienced analysts, are some of the leading causes of slow operations and time lost in QC labs. As test procedures become more complex, these errors increase and can jeopardize system operations, leading to quality and data integrity issues, costly investigations, product release delays, and even recalls.
The use of older instrumentation can also cause extensive downtime. This problem can be further exacerbated due to incompatibility with newer software, making method migration and transfer extremely difficult and error-prone. Manual management of lab assets may be flexible and easy to deploy with no additional costs but does not scale well; modern QC labs are characterized by a wide variety of digital assets, so a manual approach to asset management can be detrimental to productivity and further widen the gap between speed and quality.
These issues are further compounded by ever-evolving compliance and data quality requirements, tight deadlines, lean budgets, staff turnover, and mounting training requirements. QC labs in the pharmaceutical industry thus face an uphill task in implementing effective measures to reduce errors, optimize process development, and promote efficiency in QC labs.
Alliance iS HPLC System
To tackle these challenges, Waters has introduced the new Alliance iS HPLC System, providing up to 40%* reduction in human error through proactive error detection, simpler troubleshooting, and improved ease-of-use. This next-generation technology paves the way for QC labs to achieve first-time quality results, reduce error investigations, and shorten product release cycles.
The Alliance iS HPLC System achieves these feats thanks to its host of unique features and capabilities developed specifically to address the emergent needs of QC labs.
Incorrect solvent levels or tightening of system fittings, unverified system performance, and forgotten samples are some of the many common lab errors that lead to repeated procedures and precious loss of time. The Alliance iS HPLC System is designed to work seamlessly with Empower Software, helping to prevent common errors with pre-run verifications of the correct column, vials, plates, solvent levels, and expiration dates. This all contributes to maximized system uptime and minimized service intervention.
An intuitive, advanced instrument touchscreen interface enables guided system operation and maintenance while delivering important visual prompts and alerts. Users are notified of common process errors involving incorrect methods, missing samples, and system maintenance. In the case of the latter, automated system diagnostic pre-checks assist in meeting error reduction key performance indicators (KPIs). The user also has the option to manually troubleshoot performance issues with the help of directions provided by the system. These steps further eliminate possible system errors that may disrupt processes, saving laboratory time and money, while facilitating the timely delivery of drugs and products to consumers.
Empower Software provides full audit tracking capabilities, automatically logging actions performed on the system’s touchscreen interface into Empower audit trails. This is particularly helpful to QC lab environments, which must ensure a healthy balance in innovation toward quality products and compliance with regulatory standards.
To reduce any errors related to incorrect column usage, the Alliance iS HPLC System also works seamlessly with eConnect Column Tag Technology. This technology enables easy column identification and determination of column usage history, ensuring correct and optimal system performance at all times.
With the combination of these features in one system, fewer errors and streamlined compliance make way for quicker processes and saved time. The Alliance iS HPLC System eliminates the need to singularly choose between simplicity, efficiency, and quality by reducing the risk of common errors and improving the reliability of analytical measurements, thus boosting operational efficiency and productivity in QC labs.
Pharmaceutical QC labs function under persistent duress to achieve more with fewer resources. In the face of rising consumer demand and limited resources, QC labs must confront a rapidly evolving business landscape where compliance and data quality requirements for released products must be met within tighter timelines and smaller budgets.
Efforts to increase the speed of operations and productivity in QC labs must consider reducing common errors and instrumentation downtime, facilitating smoother method migration and transfer, streamlining asset management, and meeting compliance and regulatory standards. These problems become even more challenging due to staff turnover, increasingly complex analytical models, and inconsistent training, which results in significantly reduced productivity and quality, as well as considerable loss of time.
The Alliance iS HPLC System from Waters provides a platform of unique capabilities and expansive toolsets that complement the needs of QC labs. With a focus on reducing human error and unexpected downtime, the Alliance iS HPLC System promotes proactive error detection and simpler troubleshooting.
Through these features, the Alliance iS HPLC System paves the way toward informed decision-making and supports the QC lab’s compliant, global business network. This in turn helps cultivate a QC culture that endorses the development of safer products for human health and well-being and an enhanced working environment that positively influences employee retention and motivation.
Find out more about how the Alliance iS HPLC System can help your QC lab to successfully optimize process flows and meet industry standards of quality, compliance, safety, and product delivery – all while mitigating lost time- by visiting: www.waters.com/AllianceiS
*Based on Waters’ market research in 2022, surveying 56 global Pharma QC labs running >25 systems.