Why the Pharma Industry needs Test Advisory and Management Services?

 

The pharmaceutical industry is facing a slew of challenges owing to the changing market dynamics, a stricter regulatory environment, cost escalation, and the appearance of drug-resistant microbes. Besides, the strict competition from generic drugs is holding the industry from investing more in research and development. Instead, it is aiming to streamline the processes to improve operational excellence and optimize costs while addressing the market demand. The initiative focuses on addressing issues with inefficient manufacturing, which in turn is driving the overall cost of drugs and healthcare. 

The pharma industry is more tech-driven with technologies like robotics, AI, automation, and advanced analytics, among others, included in the value chain. These technologies, apart from increasing the productivity, quality, and efficiency of operations, are helping to reduce the cost of operations as well. Like other industries, the pharma industry is adopting digital transformation and automation to reduce manual errors and achieve quick resolutions of issues. Further, with a greater focus on quality control, digital transformation is leading to increased agility, lesser deviations, and a quicker turnaround time.

With test advisory services, the pharma industry can improve the QA focus areas, namely, tools, people, and test environment, across the SDLC. These help the industry to understand the maturity of the QA processes and practices and identify the gaps in them. The test transformation services allow the industry to implement an efficient, effective, and metrics-driven QA process. This is important to achieve value-added engagements and high performance of the infrastructure. Pharmaceutical testing allows the measurement of critical QA attributes in real-time and adjustment of running processes on the fly.

Challenges with traditional QA in the pharma industry

In the traditional way of software testing for pharma industry, the finished drug products are compared to standard specifications and rejected if they do not meet the specifications. Here, the materials are tested before and after manufacturing within a strict and tightly controlled process. The process is strictly controlled as there is uncertainty whether the specifications alone are enough to drive quality. Unfortunately, such an approach often leads to drug recalls and shortages.

In the traditional testing process, there is an inadequate understanding of the root causes of product failures. Further, since changing the established processes to incorporate broader acceptance criteria can be expensive, quality is ensured by following rigid manufacturing processes. Also, scaling up production from small batches in the laboratory can reveal new issues including the requirement of filing regulatory supplements for incremental changes to the process. These create difficulties in improving the process and achieve real-time QA with a tight feedback loop.

The remedy is in understanding how process design can lead to better quality products. This is where test advisory services can help the pharma industry in transforming and streamlining the existing QA processes to achieve business goals. These can not only improve the overall product quality but increase process efficiency, productivity, and reduce costs.

Benefits of using test advisory and management by the pharma industry

The advisory and transformation services take a comprehensive view of the manufacturing and QA processes to detect gaps and vulnerabilities. These assess QA maturity by following the best industry standards and practices and give recommendations on QA process improvements, QA automation strategies, and the roadmap for implementation. The QA consulting experts help to identify the process KPAs and measure their progress. 

Achieving quality by design: This approach focuses on designing, analyzing, and controlling the manufacturing processes to meet the product quality requirements. This includes the use of advanced tools to measure the properties of ingredients and pass on data for evaluation in real-time. Software tools can derive information about the quality of the final product batches from such data and meet the targeted quality goals. With real-time analytics, product developers can achieve a quicker and higher understanding of the process dynamics, which can lead to better scaling up of the process for commercial production.

Real-time release testing: The strict regulatory standards and quality checks that are part of any test advisory framework can lead to the scrapping of finished products, inefficiencies, and costly delays. However, real-time release testing aims at measuring the quality of the product in real-time rather than at the end of the batch. The tools used in this process gather data from inline process measurements and analyzers to derive information on the need to adjust the manufacturing process during batch execution. Real-time release testing can streamline the whole manufacturing workflow, cut down on delays, and eliminate the need for end-product quality testing. Besides, the quality information becomes part of the batch to be reused.

Conclusion

Quality by design in pharmaceutical testing can achieve consistent quality levels by allowing flexibility in the manufacturing process. The higher levels of quality achieved during the manufacturing process for the finished products can lead to better market adoption, value engagement, scalability, brand equity, regulatory compliance, and lower cost.

Resource 

James Daniel is a software Tech enthusiastic & works at Cigniti Technologies. I'm having a great understanding of today's software testing quality that yields strong results and always happy to create valuable content & share thoughts. 

 

Article Source: medium.com