Risk Management within the Global Supply Chain - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Risk Management within the Global Supply Chain
The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.

Pharmaceutical Technology

The global supply chain for the pharmaceutical industry has expanded during the past decade as companies have striven to be competitive and harness emerging technology. Foreign markets have emerged to offer lower costs for various products. Many companies find managing global suppliers and product-quality issues to be challenging. Recent industry events such as the contamination of batches of heparin demonstrate that a lack of control in the global supply chain can lead to patient harm and death, product recalls, loss of integrity, and significant financial liability for a company. Current good manufacturing practice (CGMP) regulations state that companies that design and manufacture pharmaceutical products must ensure that all components, raw materials, and product from suppliers meet predetermined specifications and that suppliers and their operations are in a state of control.

In today's climate, companies should use a risk-management program to assess their suppliers' ability to provide material suitable for the manufacture of medicinal products. A risk-management program should help companies evaluate and control the quality of their suppliers and of the supply chain. The US Food and Drug Administration's Pharmaceutical CGMPs for the 21st Century initiative is intended to enhance and modernize the regulation of pharmaceutical manufacturing and product quality. Its goal is to bring the pharmaceutical industry in line with the risk-management activities the medical-device industry uses to reduce patient and business risk. FDA's expectations are outlined in the International Conference on Harmonization's Q7, Q8, Q9, and Q10 guidelines. Several key elements can help control and limit risk throughout a global supply chain. This article will discuss risk prioritization, risk assessment, risk control, risk communication, and risk review in detail.

Risk prioritization

Deciding how to begin implementing a supplier risk-management program can be challenging for established companies, let alone for startups. A risk-prioritization matrix outlines a systematic and objective approach that helps companies select the best starting point.

One approach to developing a specific company's matrix is to create a list of manufactured and distributed products that includes key data. The following data may be considered in developing a risk-prioritization assessment:

  • Patient risk (i.e., sterile, parental, nonsterile)
  • Quality data such as nonconformances, corrective actions/preventive actions (CAPA), deviations, and customer complaints
  • Volume of product manufactured
  • Supplier history.

Figure 1: Example risk-prioritization matrix. (ALL FIGURES ARE COURTESY OF THE AUTHORS.)
These data can be entered into a table similar to that in Figure 1. The individual data categories are assigned a numerical risk-ranking value as in the following example:
  • Patient risk for parentals—3
  • Patient risk for sterile products—2
  • Patient risk for nonsterile products—1
  • High-risk supplier—3
  • Medium-risk supplier—2
  • Low-risk supplier—1.

Key quality data such as nonconformances, CAPA, deviations, and customer complaints should receive values equal to their number of occurrences.

Likewise, the risk value for the volume of product manufactured is equal to the number of lots or units produced. Typically, this value is weighted to reduce the chance that a low-risk product with a high production volume will become the highest priority. Values are multiplied to obtain a risk-prioritization score. The product with the highest score gets top priority.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here