Episodes on Quality Assurance: part 3

Personnel Assignment and Quality System

In order to ensure the quality of pharmaceutical products, it is widely recognized that it is important to secure personnel commensurate with the nature of manufacturing and quality control operations. However, in recent years, "insufficient staffing" has been pointed out as one of the causes of serious quality problems involving non-compliance with laws and regulations, such as voluntary recalls of generic drugs and business suspensions. Here, I would like to share my thoughts on this issue.

In light of the string of generic drug scandals that have occurred, the regulatory authorities have explicitly stated that they will check manufacturing and quality control systems when reviewing future approvals. It urges that efforts be made to define the necessary personnel and to secure and assign them in consideration of various factors, but this task is not easy and needs to be understood as a very difficult problem.

First of all, the situation for securing human resources differs greatly between large companies and Small and medium-sized enterprises (SMEs),  with SMEs finding it difficult to secure (hire) appropriate human resources, and the effort, time, and expense required to train them after hiring also differs. SMEs, which account for the majority of pharmaceutical companies in Japan, are at a disadvantage in this respect, and it is understood that securing and allocating personnel is not a simple, uniform process. Next, when determining the number of staff to handle a task, it is necessary to basically take into consideration the ability (knowledge, experience, etc.) of the staff and relate "the number of staff x ability (B)" to "the degree of difficulty of the task x quantity (A)". Assuming that the same work (in terms of quality and quantity) is to be performed, the number of staff in B may be two if the staff has high "work execution ability" in terms of knowledge, experience, and enthusiasm, but if not, three may be needed.