While we’re waiting for Annex 1…

The pharma industry is holding its breath in anticipation for the updated EU Annex 1 - Manufacture of Sterile Medicinal Products. Originally expected to be published as early as 2016, the new version of Annex 1, which has major updates in both structure and content, is still in draft and it is unclear at this point when it will come out. The European Medicines Agency still consider GMP Annex 1 as a high-priority work item, but the date of release continues to be a moving target – not unaffected by the uncertainty regarding Brexit.

But while we’re waiting for EU Annex 1, things are still moving on the other side of the Atlantic. Anette Yan Marcussen, Managing Consultant at NNE and Vice Chair of PDA’s Regulatory and Quality Advisory Board, gets us up to speed on what else is moving in the GMP area and shares her key takeaways from the PDA/FDA conference in September 2019:

Compliance insight – and advice – straight from the FDA inspectors

  • 42% of FDA’s drug applications in 2018 were drugs for personalized medicines
  • 62% of supply disruptions are due to quality issues and are leading to drug shortage

According to the FDA inspectors, the single most important thing to mitigate quality issues is that executive management takes the ultimate responsibility to ensure quality across the organization.

New Inspection Protocol Project (NIPP)

FDA is developing a new tool for inspections. The purpose is to standardize an electronic inspection protocol, and on that basis create a semi-automated report. Data output can be used to focus future inspections. FDA has already started using this new tool in 2018 on sterile pre-approval inspections. Rumors tell us, that there might also be a secret quality scale (from -2 to +2), which FDA uses to classify companies.

Quality culture and drug shortage

Overall, quality culture is very hot. FDA has observed that, generally, the closer the owner of the pharmaceutical quality system is to the CEO of a given company, the better the quality culture.

Furthermore, the FDA NIPP protocol includes quality culture questions – and more than 100 FDA inspectors have participated in the PDA Quality Culture course.

Artificial intelligence and augmented reality are moving into pharma

More and more companies are using artificial intelligence (AI) and augmented reality (AR). Takeda, for instance, is using AI it for line clearance on packaging lines and J&J use it for routine environmental monitoring and sees benefits like reduced time and errors and an increased efficiency of sampling.

About the 2019 PDA/FDA Joint Regulatory Conference

The 2019 PDA/FDA Joint Regulatory Conference took place on 16-18 September. This year’s theme was Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision, and the conference explored the continuing development of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms.