Quality assurance guidelines

Which guidelines follow for qa? And when is qa born?

There are several guidelines that talk about quality assurance; also, almost any regulatory norm specifies the minimum requirements that the quality management system (QMS) should have to comply with a specific regulatory entity.

I will, however, suggest that you firstly look for the ICH Q series guidelines, speciffically the ICH Q10 wich is all about the Pharmaceutical Quality System, wich is also the base ground for a lot of quality guidelines issued worldwide. Then, if you want more specific insight, I would suggeset to look for the regulation norms directly, since they are more specific and you will have a better understanding of what the health authorities expect you to have as QMS.

Here is the link to the Q10 guideline from the ICH:

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The Food and Drug Administration (FDA) report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”14 was an introduction to quality by design (QbD), the concept that quality should be built into a product. According to the FDA report “Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach,” QbD involves a thorough understanding of the product and the process by which it is developed and manufactured, as well as a knowledge of the risks involved in its manufacture and how best to mitigate them.1

Three other agency Guidance for Industry titles:

“PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance”
“Q10 Pharmaceutical Quality System”
“Process Validation: General Principles and Practices”
further describe this new thinking and introduce a regulatory framework intended to encourage development and innovation within the pharmaceutical industry.2,4

While intended for the twenty-first century, each of these documents reflect basic principles first proposed after World War II by Dr. Joseph Juran and Dr. W. Edwards Deming. As agency guidance is increasingly aligned with the principles of these founding fathers of modern-day quality, it is worth exploring Juran’s and Deming’s views on leadership and learning how they evolved from engineers to philosophers in management.

After World War II, Juran and Deming both traveled to Japan to help rebuild the country’s economy. Their efforts helped revolutionize the quality system of Japan and started a quality revolution that the rest of the world could not help but notice. Evidence of Juran and Deming’s work is present today in FDA guidance documents and regulations, as well as in other industries that have quality system regulations.

Leaders in the pharmaceutical industry must recognize that as quality systems have evolved, so too have the expectations and responsibilities they must fulfill. Quality cannot be an afterthought with any product, nor can it be the responsibility of any one department. Quality must be instilled within an organization and designed into processes and systems. Most importantly, perhaps, the culture of quality must begin with the leaders in the organization. These concepts are also detailed within the “Q10 Pharmaceutical Quality System” Guidance for Industry.3

In 1925 Juran joined the Inspection Statistical Department at Western Electric, where he was in charge of integrating statistical sampling and control charting techniques into the system. At this time, quality management systems were focused solely on the end product. But Juran saw things differently. He recognized that this approach was missing something—the human element. Some of the biggest hurdles organizations faced, he realized, were human relations problems and employee resistance to change.5Rather than confining quality to a specific department, he said, “It is most important that top management be quality-minded. In the absence of sincere manifestation of interest at the top, little will happen below.”6

Juran later moved on to management consulting, and by 1951 had written the first edition of his landmark Quality Control Handbook.7 This publication attracted the attention of the Japanese and earned him an invitation to work with 10 manufacturing companies, including Takeda Pharmaceutical Company, the largest pharmaceutical company in Japan and Asia and one of the top 15 in the world.8,9

Dr. W. Edwards Deming, who had a very similar philosophy to Juran’s, also traveled to postwar Japan. He saw that the root cause of many quality issues came from top management. At that time quality issues were frequently attributed to the worker—and often are today, as well. Deming saw through this and identified organizational culture as a root cause.10 Quality was not something that could be attained without first designing an entire organization and related processes around it; these concepts are reflected today within the FDA documents mentioned above.2,4

Deming began his career working for the US Department of the Census and the Bureau of Labor Statistics. Here he applied the principles of Walter Shewhart by integrating statistical process control to an operation. Shewhart identified problems in manufacturing as the result of either common or special variation. Common variation, which is inherently present in a process, represents the “noise” in a system. Special variation is assignable variation that results in a significant process change.10

Deming took this one step further and developed a philosophy of management based largely on Shewart’s principles. Management, he said, can lead by understanding what he called his “System of Profound Knowledge”.11