The 2^nd International Summit on GMP, GCP & Quality Control took place recently at the DoubleTree by Hilton Hotel Chicago – North Shore Conference Center. Oriented toward the life sciences industry, the conference brought together a unique, international blend of pharmaceutical & medical devices companies, business entrepreneurs, pharmaceutical consultants, leading universities, and research institutions.

During the Keynote Forum, Gerard Pearce of SQA Services, USA provided the theme for this year’s summit: “Communication, collaboration, and consistency with regard to interpretation and implementation of regulations.” He emphasized that ensuring the compliance of cGMP standards with various global regulatory authorities is an immense task. He went on to inform us that companies will find that regulatory authorities don’t often agree on cGMP standards; so we, as compliance professionals, should be aware of the differences among regulators. He also noted that a manufacturer looking to maintain global regulatory compliance should expect to incorporate the most stringent requirements in order to comply with the various global standards.

Two of our consultants, Jackie McCulloch and Courtney Woodson, were asked to discuss, “Maintaining Your Laboratory in a State of Control: The Data Integrity Challenge,” citing FDA enforcement trends and highlighting possible LIMS system and procedural controls. Data integrity was also discussed from the standpoint that electronic laboratory systems have key indicators for claiming data authenticity.

Jackie McCulloch also discussed “The Evolution of the Medical Device 510(k) Process,” which was based on our recent thought leadership. Her presentation discussed how the 35-year old “fast track” process for medical device approval evolved to become the process many medical device companies use today.

Some of the key trends and takeaways from the summit include:

• • The link between patient safety and the lack of manufacturing quality significantly impacts the risk/benefit ratio. Although a prerequisite for approval, companies should continuously evaluate the risk/benefit ratio in order to determine if it is still positive.
  • Clinical trials have gone digital, making it difficult to maintain GCP while running studies in less developed countries, such as Uganda. Without the internet, informed consent and data management can be cumbersome.
  • It is important to remember that the cost of poor quality is not about revenue lost to scrap product, but rather patient lives lost when poor quality product makes its way to the marketplace.
  • “Quality is not a destination, it is a constant journey.” Thus, continuous improvement is necessary, and companies must stay up to date on the changes in the regulatory landscape.

The summit created an ideal platform to share experiences and foster collaboration across industry and academia. This is valuable, particularly since we all share a common goal: to improve the manufacturing quality of healthcare products around the globe.