Glossary

Statistical Process Control (SPC)

What is Statistical Process Control (SPC)?

Statistical Process Control (SPC) is a methodology used in the pharmaceutical industry to monitor and control manufacturing processes. It involves the use of statistical techniques to measure, analyse, and control process variations to ensure consistent product quality.

The benefits of implementing SPC in the pharmaceutical industry include:

  • Improved product quality and consistency
  • Reduced manufacturing costs by minimizing waste and rework
  • Enhanced regulatory compliance by demonstrating process control
  • Faster problem-solving and root cause identification
  • Continuous process improvement through data-driven decision making

Why is SPC important in pharma?

Statistical Process Control (SPC) is important in the pharmaceutical industry for several key reasons:

  • SPC enables pharmaceutical manufacturers to monitor and control critical process parameters and product quality attributes, by detecting and addressing variations.
  • Implementing SPC is a regulatory requirement for pharmaceutical companies. Regulatory bodies like the FDA expect manufacturers to demonstrate statistical control of their processes.
  • SPC provides a data-driven approach to identify opportunities for process optimization and continuous improvement. By analysing process data, manufacturers can reduce waste, improve efficiency, and enhance overall productivity.
  • SPC tools like control charts enable early detection of process problems. This allows for faster investigation and implementation of corrective actions, minimizing the impact on product quality.

What are the key features of SPC?

Statistical Process Control (SPC) helps pharmaceutical companies ensure regulatory compliance:

  • By using statistical techniques like control charts, pharmaceutical companies can demonstrate to regulators that their processes are in a state of statistical control.
  • Implementing SPC is a regulatory requirement for pharmaceutical manufacturers, as it helps ensure consistent product quality and patient safety.
  • Regulatory bodies like the FDA expect pharmaceutical companies to utilize SPC to monitor critical process parameters and quality attributes.
  • SPC enables early detection of process variations or out-of-control conditions through statistical analysis.