Best Practices for Manufacturing Active Pharmaceutical Ingredients

This 3-day intensive course prepares attendees to meet the challenges they face in the heavily regulated pharmaceutical industry. API manufacturers must be aware of local, regional and national regulatory agencies’ enforcement activities that are applied to API production and develop a strategy to compete successfully in the current world economy. Manufacturing in the 21st century is shifting from manual processes that depend on subjective decision-making to automated processing that provide greater control and flexibility. This new paradigm focuses on product life-cycle from development activities to commercial production and finally product discontinuation.

The initial topic discussed is management’s roles within the organization and outside of the organizational structure that contribute to the success of the operation. Other topics focus on the various manufacturing functions using classical, enhanced or a combination approach. Risk management is an important tool in the decision making process related to quality and production systems development that emphasizes patient safety and helps to maintain a healthy regulatory environment. Throughout the program there are interactive class exercises. On the last day of the course, participants are put into small groups and each group receives a list of simulated regulatory observations based on actual inspections. The groups evaluate the observations and then prepare a written response to the regulatory authority explaining their activities to remediate the deficiencies. The exercise is a valuable opportunity to develop approaches with your colleagues and build lasting contacts.