Consulting company Compliance Implementation Services in Media, PA, has named David Greeley (pictured) VP for GMP compliance. Greeley will lead the CIS group that works with clients to meet cGMP requirements in the areas of document control, inspection readiness, internal system audits, development of key performance indicators and training, says a company announcement. We corresponded with Greeley via email on his view of the manufacturing compliance road ahead.
What do you make of the recent flurry of facility activity--sales, closings, construction, expansion--in both developed and developing nations?
David Greeley: The industry is continuing to feel the pressures of an ever-evolving global landscape, both politically and financially. Developed nations continue to focus on moving manufacturing to third parties, while the focus of developing nations is to provide additional options for companies looking to move production offshore.
A good example of this evolution is China's new Drug Manufacturing Quality Management Standards issued by the State Minister of Health in January. The GMP standards are a significant step forward with a focus on a more comprehensive quality control system. Many emerging markets are ahead of where many of us thought they would be 10 years ago.
What does your crystal ball show for pharma and biotech manufacturing outsourcing 5 years from now?
Greeley: Over time we may see the majority of commodity-based manufacturing overseas with specialty and high-risk products staying in the U.S. for the foreseeable future. Manufacturing sites in China and India now comprise 45% of all FDA-registered foreign sites, having increased from 30% in 2002.
Building on that theme, the trend is toward more synergistic alignment all up and down the value chain that speeds time to market, maintains compliance and positively impacts the bottom-line. That alignment will continue to develop as policies, quality systems and technology evolve.
How does a globalizing pharma industry keep pace with the regulatory requirements of the countries they wish to enter, as well as changing requirements where they currently do business?
Greeley: The pharmaceutical industry has embraced an ever-evolving and more complex outsourcing model as it relates to development, testing and manufacturing. We will see the same model evolve in quality and compliance outsourcing. Drugmakers will seek expertise on compliance strategies abroad, advice on overcoming regional challenges, and the implementation of robust quality systems.
How do big-ticket items like new technology and globalization jibe with CIS's efforts for its small to mid-size company clients?
Greeley: Their needs are very different depending on where the company is in development and what its objectives are. The small drugmaker may need to select a CMO and thus will need a compliance vendor criteria/selection program. The mid-size pharma may be moving into a global space and need infrastructure for compliance and supply chain, or perhaps a quality management system that's not yet established.
What do you hope to accomplish at the CIS Manufacturing Practice in the next 18 months?
Greeley: The GMP team will grow, building on a client base of large, mid-size and small pharma companies. We are positioning the consulting team to meet market needs, including virtual training models, SOP development, mock audits, gap analysis and management strategies. We're also expanding compliance consulting, reaching internationally, specifically targeting small to mid-sized life science companies.
- here's the announcement