On Establishing the Required Structure for a Modern QA Department [Part 3]

2. The Role of the QA Department in Recent Cases of Misconduct

In recent years, various pharmaceutical manufacturers have received administrative penalties.

Although such administrative disciplinary actions occurred in the past, over 20 administrative disciplinary actions have been imposed on manufacturers in the few years since the 2020 incident in which a hypnotic ingredient was mixed into a pharmaceutical product. 

It appears in most of these cases, the misconduct did not begin recently; rather, longstanding misconduct was only recently revealed. Therefore, basically, the implemention of the previously mentioned revised GMP Ministerial Order occurred independently of the implementation of those misconducts.

Why did these misconducts occur？Or why were companies forced into situations leading to misconduct? Reasons may vary from case to case. However, in many instances, a contributing factor was the QA department’s failure to function properly within the GMP organization. Furthermore, particularly when responsible executive officers failed to fulfill their duties, proper production control and quality control across the organization could not be achieved, eventually leading to misconduct.

Driven by stable supply and profit targets, unreasonable or reckless production schedules may be likely created. In this situation, changes, OOS (Out-of-Specification) results, and deviations could not be properly handled. Consequently, to meet delivery deadlines, the QA department was cornered into situations where its role could not be fully exercised, leading to  inappropriate release decisions. This was seen in numerous cases of misconduct.

When supply and profit are prioritized, the necessary amount of the product must be produced to meet those goals. If a manufacturer continues to produce a product, and even increases production capacity, operators are obviously required. However, QA personnel are not directly involved in production. Consequently, in some cases, while staff of the production department was increased, staffing for non-production departments like QA was neglected. 

In other cases, production was prioritized, meaning experienced staff were allocated to the production department, while personnel without sufficient experience were assigned to the QA department.

If we want to pursue good quality, the QA department's role is naturally significant, and suitable personnel should be secured. However, it is undeniable that in some manufacturers, the QA department has been undervalued as supply and profit took precedence.

Moreover, in some cases, excessive priority was placed on supply. As a result, necessary information was not shared with the QA department. 

For example, in the rush to manufacture and supply pharmaceutical products, operations continued even when deviations occurred, without proper deviation handling. 

In such cases, the occurrence of the deviation was not reported to the QA department, preventing QA from fulfilling its responsibility of deviation handling. 

Similarly in some cases, changes were implemented on-site without reporting them to the QA department, meaning QA could not conduct change control. In fact, changes were implemented at the site without QA approval.