The Role of Statistics in Pharmaceutical Quality Assurance

pharmaceutical quality assurance

A fundamental requirement of the pharmaceutical industry is to ensure the safety and effectiveness of products. Pharmaceutical quality assurance is a vital step in this process and helps to keep all steps and processes in line with good manufacturing practices (GMP). When documentation and data are consistently accurate, then pharmaceutical companies are able to operate and perform as expected.

Within pharmaceutical quality assurance roles, this tracking of data is where statistics comes into play. Statistical methods are essential to the operations of any pharmaceutical manufacturing facility, ensuring alignment with standards of quality. Especially considering advancements in technology, coupled with new and increasing demands for rapid drug delivery, statistics are more important than ever. Continue reading to dive into the role that statistics currently plays in these processes.

Observing and Monitoring Data as It Becomes Available

Students taking pharmaceutical courses in Toronto at the Academy of Applied Pharmaceutical Sciences come to learn that organized and streamlined processes, whether dealing with hazardous materials or creating audits, are essential to the success of any operation. Careful consideration for each step of each recorded process enables products to arrive on the market safely and seamlessly.

However, the benefits don’t stop there. Designated processes help those in quality control to apply statistical methods to each step of the process, allowing them to observe and monitor the data as it comes in.

pharmaceutical quality assurance

Pharmaceutical quality assurance relies on statistics for tracking data

Paying close attention to the products, the manufacturing process and the results, quality control professionals are able to raise the alarm at the first sight of error. Additionally, they can use statistical methods to measure variables throughout the stages of each process to compare them, discover the source of variability and find a solution.

Recording Variability Helps Facilitate Pharmaceutical Quality Assurance

Observing and monitoring data helps those in pharmaceutical quality assurance spot an issue, and recording data allows for future mistakes to be prevented. One emerging statistical method proving to be very useful for quality assurance purposes is PAT: Process Analytical Technology. PAT is expected to produce gains in:

  • Quality
  • Safety
  • Efficiency
  • Automation
  • Continuous processing

PAT is able to achieve these gains through timely measurement and recording of important data. For example, PAT could be used to record biological, chemical, and physical attributes that shed light on the product’s current state.

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Statistics also help assess the safety and effectiveness of drugs

Students who study at AAPS become familiar with the Standard Operating Procedures (SOP), Records of Training, Change Control, Deviation Reports, and more, which all require accurate, detailed reporting of outcomes. With an inclination to this statistical mindset, students are prepared to succeed in the workplace upon program completion.

Statistical Methods as Well as a Statistical Way of Thinking

Apart from the process-driven need for statistics, pharmaceutical school helps students adopt this statistical mindset when it comes to approaching all aspects of quality assurance. In manufacturing industries, product effectiveness is clearly defined and measured by product performance.

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Attention to detail and a statistical way of thinking help quality assurance professionals succeed

Understanding the role that statistics plays in product performance is important for any pharmaceutical quality assurance professional. With greater availability of statistical data, improved collection of records and more accurate reporting, a more comprehensive idea of the product’s safety and efficacy can be developed. 

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