Over 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?