Rx-360 exhibited at the PDA Annual Meeting in Las Vegas, spreading the word of the organization’s mission and progress. At the PDA meeting there were many interesting presentations about manufacturing science but there were also a few key take-a-ways about new GMP developments:
- At the Visual Inspection Interest Group, PDA Members discussed recent issues with glass containers that have resulted in recalls and/or near misses. The group discussed how glass vendors and pharmaceutical companies can work together to improve glass quality and handling.
A survey on glass usage is currently being prepared and anyone interested in participating in the survey should send their contact information to Martin VanTrieste at mvantrie@amgen.com.
- In addition, Tor Graberg, on behalf of PIC/S and EU inspectorate, discussed new cGMP inspection expectations pertaining to ICH Q10. EU GMPs will need to be updated to align terminology with ICH Q10, especially related to Management Responsibilities.
In future inspections the EU will expect to meet with top management during inspections either vice presidents or CEOs to understand the quality culture. Their new view is that a GMP violation is not due to operator error but failure of senior management. It will no longer be acceptable to meet just with the head of Quality Assurance or Quality Control during inspections.
In other words, the role of management is critical (now defined by ICH Q10) and a lack of resources for Quality is a GMP violation and that senior management is responsible and accountable to assure that Quality is properly resourced.