A typical problem

Scientists and technologists focused on discrete elements of registration of CMC data, without the time for or experience of risk management in the end-to-end supply-chain.

Some points to consider

• Have the relevant CMC experts been involved in risk management?
• Is there a map of the end to end supply-chain?
• Have key data on risk vulnerability been collected and analysed?
• Are there risk mitigation plans in place?
  
   See case study 1

A typical problem

A contractor or supplier has been selected on limited technical grounds, but does not have the full capability to meet projected future needs. It could be insufficient capacity for growth, lack of a vital technology, process or skill set, poor financial solvency, conflict of competitive interest – the list goes on.

Some points to consider

• Is there a sufficiently robust process of supplier identification and selection in place?
• Were all key stakeholders involved in the selection process?
• Was a structured decision making process used, clearly identifying qualifying criteria?
• Remember, the quality audit is vital, but not sufficient for decision making
  
   See case study 7

A typical problem

How to determine a validation scale for commercial operations at each GMP supply source? Too small a scale and the contractors will have to produce at an uneconomic frequency. Too large a scale and there can be a high risk financial write off and need to re-manufacture emergency supplies.

Some points to consider

• Are the bounds of uncertainty for sales volume and regulatory approval timings defined?
• Is the sourcing strategy agreed?
• Has sufficient information been collected on manufacturing and release lead-times, shelf life, process yield losses, routes and costs?
• How much ‘what if’ modeling has been carried out?
  
   See case study 6
  
  

A typical problem

• Drug not available at site in time for study initiation because of:

- lack of coordination with the contract manufacturer
- inadequate service from freight forwarders and couriers
- delays in customs clearance
- degradation of temperature sensitive materials
- damage to material through inadequate transit packaging
- material expiry
- Good Distribution Practice has been compromised on shipment

Some points to consider

• Is supply management on the project team agenda?
• Are clear points of contact nominated?
• Is there a simple mechanism to allow for contractor lead-times and constraints?
• Are SOP’s written and agreed for distribution logistics?
• Is a preferred specialist logistics provider identified?
• Have transport tests been carried out on the shipping container?
• Is there an inventory control system in place?
  
   See case study 5

A typical problem

General uneasiness that ‘best value’ is not being achieved in CRO’s relationships, evidenced by some or all of the following:

- unavailability of key skill sets
- frequent change orders
- unexpected work invoices
- excessive pass through costs
- activities not adding sufficient value
- key clinical and scientific staff tied up in areas they are not experienced or trained in

Some points to consider

• Were all relevant players involved in project scope generation?
• Was the original scope statement detailed enough?
• How clear were mutual expectations throughout the tendering process?
• Were the key interfaces defined?
• Are staff trained in managing outsourced relationships?
  
   See case study 3