group meetingOver the past few years, CMO partnerships have grown by approximately 11% annually and are projected to continue increasing at a steady pace. According to Global Industry Analysts, Inc. (GIA) the global market for pharmaceutical contract manufacturing should reach $40.7 billion by the year 2015. With partnerships growing, increased challenges are emerging throughout each phase of the product lifecycle process. Below are some of the most prominent issues/concerns in each phase:

START-UP PHASE

  • Multi-customer and multi-regulated facilities
  • Product segregations
  • Regulatory expectations
  • CMO due diligence

SELECTION PHASE

  • Product Approval Inspections
  • GMP Inspections
  • Validations
  • Regulatory expectations

GOVERNANCE PHASE

  • Right level of governance to achieve transparency and accountability
  • Auditing
  • Metrics
  • Risk Management
  • Regulatory expectations

DELIVERY PHASE

  • Ongoing development/ manufacturing
  • Product distribution
  • Vulnerabilities in the Supply Chain
  • Control and Visibility in Packaging, Data Integrity and Shipping
  • Customs Issues
  • Regulatory expectations

Now more than ever, the partnership between contract manufacturing, development organizations and FDA must be collaborative to ensure high-quality, safe and effective medicines for patients. ISPE’s CMO Executive Workshop is the first step to understanding the important components of quality contracts and building relationships.

Tell us about your CMO- Owner Company Relationships, which phase do you find most challenging? What advice do you have for those trying to improve these relationships?