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:
Multi-customer and multi-regulated facilities
CMO due diligence
Product Approval Inspections
Right level of governance to achieve transparency and accountability
Ongoing development/ manufacturing
Vulnerabilities in the Supply Chain
Control and Visibility in Packaging, Data Integrity and Shipping
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?
The ISPE 2023 Annual Meeting & Expo agenda is always packed with sessions offering pharmaceutical professionals opportunities to engage in industry-critical conversations. Several of ISPE's regulatory initiatives took center stage during the technical sessions in the Regulatory and Quality track at the
Just around the corner on 11-12 December, join us for a wealth of knowledge sharing, uniting industry experts to engage in discussions that unveil their insights and experiences through the 2023 ISPE Pharma 4.0™ and Annex 1 Conference.
On Wednesday, 18 October 2023, Dr. Celia Lourenco, Associate Assistant Deputy Minister of Health Canada's Health Products and Food branch, presented a keynote address titled “Advanced Manufacturing and Other Trends Supporting Access to Medicines for Patients” at the