What is it about?
This paper investigates the application of statistical process control (SPC) for two tablet inspection characteristics, average weight and hardness, during in-process control. SPC is a statistical technique used to monitor and control processes to ensure they are operating within specified limits. The authors found that SPC could be used to evaluate the current state of manufacturing control for both tablet characteristics and to determine the consistency and steadiness of the process. They concluded that SPC is a crucial integral part of product manufacturing good practices and that the product value could be evaluated through the degree of compliance with good pharmaceutical practice (GPP).
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Why is it important?
This short communication article is important because it demonstrates the effectiveness of statistical process control (SPC) in ensuring compliance with good pharmaceutical practice (GPP) in tablet manufacturing. SPC can be used to monitor and control critical process parameters, such as average weight and hardness, to ensure that tablets meet quality standards. This is essential for ensuring the safety and efficacy of pharmaceutical products. Here are some of the key benefits of using SPC in tablet manufacturing: Improved product quality: SPC can help to identify and correct defects in the manufacturing process, leading to improved product quality. Reduced costs: SPC can help to reduce costs by preventing defects and rework. Increased efficiency: SPC can help to improve the efficiency of the manufacturing process by identifying bottlenecks and inefficiencies. Improved regulatory compliance: SPC can help to ensure compliance with regulatory requirements, such as those of the FDA and EMA. Overall, the article provides valuable insights into the application of SPC in tablet manufacturing and highlights the importance of this tool for ensuring product quality and compliance with GPP.
Perspectives
A Novel Perspective: SPC as a Proactive Tool for Pharmaceutical Innovation While the article primarily focuses on the application of SPC for quality control in tablet manufacturing, a novel perspective emerges: SPC as a catalyst for pharmaceutical innovation. Beyond its traditional role in ensuring product quality, SPC can be leveraged to drive innovation in several ways: Process Optimization: Identify Hidden Variation: SPC can uncover subtle variations in manufacturing processes that might otherwise go unnoticed. This knowledge can be used to optimize processes, reduce costs, and improve efficiency. Predict Failures: By analyzing historical SPC data, manufacturers can identify patterns that may indicate potential failures. This proactive approach allows for preventative measures to be taken, preventing costly downtime and product recalls. Product Development: Design of Experiments (DOE): SPC principles can be applied to DOE to optimize product formulations and manufacturing processes. This can lead to the development of new products with improved properties and reduced costs. Risk Assessment: SPC can help identify potential risks in the development and manufacturing of new products. This information can be used to mitigate risks and ensure product safety and efficacy. Continuous Improvement: Kaizen Philosophy: SPC aligns well with the Kaizen philosophy of continuous improvement. By using SPC to monitor processes and identify areas for improvement, manufacturers can create a culture of innovation and excellence. In essence, SPC can be more than just a quality control tool; it can be a strategic asset that drives innovation and competitiveness in the pharmaceutical industry. By embracing SPC as a proactive tool for process optimization, product development, and continuous improvement, manufacturers can position themselves at the forefront of pharmaceutical innovation.
Independent Researcher & Consultant Mostafa Essam Eissa
Read the Original
This page is a summary of: Application of statistical process control for spotting compliance to good pharmaceutical practice, July 2018, FapUNIFESP (SciELO),
DOI: 10.1590/s2175-97902018000217499.
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