Two years ago, eight medical product companies in Japan were found to have violations of GMP as well as the Japan Pharmaceuticals and Medical Devices Act. Enforcement has been public in Japan. Two companies have since changed ownership. In general, many quality measures have been discussed between authorities and pharmaceutical industry, including securing appropriate human resources, strengthening audit programs, improving post approval change procedures, securing the whistleblowing system and so on. The concept of Quality culture remains an issue here.
FDA’s thoughts on Quality Culture were explained in a 2015 FDA webinar. They embrace the philosophy that every decision made every single day in an organization impacts its quality compliance and therefore consistently making good decisions can result in creating a strong quality culture.
Quality culture is also described as a work environment in PIC/S DI guidance (6.3.1) in 2021.
In a Nov 26, 2019 White Paper on labor economy, the Japanese authority MHLW, said that if corporate human relations are good, people feel comfortable working. This author would like to initiate a discussion on the impact of job place human relationships on organizational quality culture.
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