For sponsors outsourcing all GMP activities it may seem as though all of your GMP suppliers are critical.  However, not every supplier performs the same service, manufactures the same type of product, or provides services at the same clinical phase of product development.  The question often asked is how to rank the criticality of GMP suppliers.  There are a variety of metrics, methodologies, rankings and sub-rankings but it all comes down to the supplier’s criticality to the sponsor.  To answer this ask yourself the following questions: 

Question 1:  Which of my suppliers contribute materials to or manufacture/process my product?  Suppliers in this category are critical and are often designated as Tier-1 Suppliers. 

• Tier-1 suppliers are those that provide regulatory starting materials, manufacturers of drug substance/drug product, producers of product contact containers, and suppliers of other materials, such as desiccants and rayon coil that touch the product.

Question 2:  Which of my suppliers are responsible for GMP testing?  Suppliers in this category are also critical and are often designated as Tier-1 Suppliers

• Tier-1 suppliers will likely include GMP labs performing release and stability testing, and stability storage facilities (if a different supplier than the testing lab).    

Question 3:  Which of my suppliers provide packaging and labeling services and product storage/distribution functions? Suppliers in this category are generally lower (but still important) in criticality than Tier-1 suppliers and are often designated as Tier-2.

• Tier-2 Suppliers may include secondary and tertiary packagers, primary/secondary container labeling and kitting, product storage, product distribution to clinical sites and other storage depots. Third-party label printing companies are also Tier-2 suppliers.

Question 4:  Which of my suppliers perform GMP service functions rather than product manufacturing and testing? Suppliers in this category may be designated at Tier-3.

• Tier-3 Suppliers include individual consultants and consulting companies, software validation companies, suppliers of electronic platforms used for data storage, e-signatures, databases, etc.

Question 5:  Which of my suppliers have frequent problems? 

• Suppliers with frequent out of specification investigations, unplanned deviations, product rejections, retraining of personnel, high employee turnover, equipment failures, and overall poor regulatory coompliance and inadequate service.

Prioritization – Tier 1 suppliers are audited most frequently, followed by Tier-2 and Tier-3 suppliers.  Problematic suppliers rise to the top of the list since their issues need to be addressed urgently. 

Discover how Eastlake Quality Consulting can author a robust phase-specific supplier qualification procedures and perform on-site and remote audits.