Posts Tagged ‘CMO’

Managing CMO Quality: A Critical Component in the Virtual Supply Chain

Tuesday, September 25th, 2012
Managing quality at your CMOs is a critical component in developing a successful virtual supply chain and CMO relationship. A comprehensive quality strategy involves a wide range of functional participation, including: quality control, quality assurance, compliance, regulatory, technical operations, IT, planning, supply chain and manufacturing. When developing a quality and compliance strategy, one must determine the criteria and minimum standard that the CMO must meet, based on their entire site performance. Performance points of interest are:
1. Corporate QA Systems
2. Specific compliance history at the plant
3. Comprehensive on-site audit
4. Past Track Record = Future Performance
While your CMO relationship begins before the contract negotiations, the negotiations process is a key event in defining your continued relationship. Try to use your contract template as the base agreement to avoid changes to language. Clearly define who is responsible for what. Do not underestimate the time it takes to develop the quality agreement; simple agreements can take up to two months, while more complex agreements can take three to five months.
Additionally, become familiar with the organizational structure of the CMO and site personnel.  A few questions to ask:
1. Who is the top Quality person at the site, and do they report into the plant manager or to HQ QA?
2. Was there a review of the quality systems and training records?
3. Who is responsible for product release?
4. What are the change control procedures and SOP’s?
5. Are the systems validated?
Quality and master agreements may set the rules, but the goal should be to build a strong relationship with your CMO and rarely refer to the contract.
To learn more about managing quality at your CMO and performance monitoring with quality KPIs, please see our recent conference presentation.
Bill Connell

Managing quality at your CMOs is a critical component in developing a successful virtual supply chain and CMO relationship. A comprehensive quality strategy involves a wide range of functional participation, including: quality control, quality assurance, compliance, regulatory, technical operations, IT, planning, supply chain and manufacturing. When developing a quality and compliance strategy, one must determine the criteria and minimum standard that the CMO must meet, based on their entire site performance. Performance points of interest are:

  1. Corporate QA Systems
  2. Specific compliance history at the plant
  3. Comprehensive on-site audit
  4. Past Track Record = Future Performance

(more…)

Tags: ,
Posted in Uncategorized | No Comments »

Managing CMOs from a Customer’s Perspective – A Focus of the ISPE Supply Networks Conference

Monday, July 9th, 2012
On June 7, 2012, I presented at the International Society for Pharmaceutical Engineering (ISPE) Supply Networks Conference (link to conference website) held in Baltimore, Maryland.
Attendees were mostly ISPE members with backgrounds in technical services, quality, and manufacturing in the pharmaceutical (“pharma”) and biotechnology (“biotech”) industry. 50% of the audience was big pharma members.  Also in attendance were suppliers to pharma and biotech, including API manufacturers.  The conference typically targeted discussion of supply chain issues from an educational point of view that most members were not familiar with. Members received educational credits by attending.
I spoke as part of the Designing and Establishing Supply Networks track in a session titled “Quality Expectations and Challenges in the Global Supply Network”.  My topic was Managing CMOs from a Customer’s Perspective (link to presentation). This included the issues involved in successfully selecting and managing a CMO (“Contract Manufacturing Organization”), taking the viewpoint of a virtual pharma company, not a big pharma company.  Significant technical and supply chain resources are needed to manage a large CMO network; therefore, a virtual pharma has to rely more on the CMOs technical capability because of their limited staff to support a CMO network.
Following the presentation, I received some interesting questions including, one asked by someone at a large pharma company where they routinely negotiate cost savings into their CMO contracts at the beginning of the relationship: Why does virtual pharma focus more on the CMO technical capability and less on cost?  My response was that a larger pharmaceutical company appears to have more leverage in negotiating financial terms than a virtual smaller pharma, which is primarily focused on the quality, capacity, and technical capability of the CMO. Cost is important but not the most important issue.
Another question was: Why is it so important to build a relationship with the CMO versus a supplier? My response was that this is due to the set of requirements of a small virtual pharma, needing a CMO that has the right technical, quality and capacity capabilities and because the virtual pharma does not have the leverage that big pharma has in dealing with CMOs.It is much more important to build a strong relationship between the two companies and make sure that negotiated agreement represents a “win-win” for both parties.
Overall this conference provided an excellent forum for industry professionals to discuss and learn about biopharma supply chain issues.  Please see my presentation (link to presentation) for more information and let me know if you have any questions or comments on this topic.
Bill Connell (link to bio), Vice President & Supply Chain (link to SC service page) Practice Leader

On June 7, 2012, I presented at the International Society for Pharmaceutical Engineering (ISPE) Supply Networks Conference held in Baltimore, Maryland.

Attendees were mostly ISPE members with backgrounds in technical services, quality, and manufacturing in the pharmaceutical and biotechnology industry. 50% of the audience was big pharma members.  Also in attendance were suppliers to pharma and biotech, including API manufacturers.  The conference typically targeted discussion of supply chain issues from an educational point of view that most members were not familiar with. Members received educational credits by attending.

(more…)

Tags: ,
Posted in Uncategorized | No Comments »