American Aerogel

american 
Preparing a pharmaceutical industry supplier for a cGDP audit.
 
American Aerogel (http://www.americanaerogel.com) develops and manufactures performance-leading aerogel-based insulation products currently used in thermal packaging systems for the transportation of valuable biomedical, pharmaceutical, and medical devices for the clinical trial, commercial distribution, and diagnostic markets. Their products enable customers to ship temperature-sensitive items using smaller packaging at lower cost with greater assurance.  Custom solutions are designed using half the cooling power of typical traditional cold chain shipping options. 

American Aerogel reviewed their compliance across their manufacturing organization. They anticipated tougher assessments from current and potential clients as the trend to assess critical-to-quality component suppliers like American Aerogel, as well as similar contract manufacturers or ‘product contact’ suppliers increased.  The assessments conducted by clients as part of supplier qualification are typically trending towards FDA cGMP guidelines. American Aerogel requested a third-party objective assessment of their current processes and quality management system based on these cGMP guidelines.

Objectives
The engagement required a top-down approach starting with document process steps and finishing with recommendations for mitigation strategies. The focus of the engagement was to:
  • Process map the current manufacturing operations from raw material receiving to outbound shipping operations in order to better understand potential compliance risks.
  • Review the quality management systems documentation and execution currently in place.
  • Assess FDA cGMP regulatory compliance risks in current practices and quality management systems.
  • Document findings and identify high risks in a technical assessment.
  • Recommend risk mitigation strategies to improve compliance for identified high risks.
Value to American Aerogel
The mangement team identified the value of this project in two key areas:
  • Understand compliance risks in current manufacturing practices and quality management system.
  • Identify high risks and have a ‘road map’ to mitigate the gap.
Methodology
The assistance provided to American Aerogel for the preparation for a cGDP audit were:
  1. Process map current manufacturing operations.  A map of the current manufacturing operations was developed.  The process steps, standards and procedures, training systems, and product handling approach identified drove the risk assessment.
  2. Conduct risk assessment of manufacturing operations.  The current process, quality management system, monitoring and controls, and actual practices were assessed to identify opportunities to mitigate any FDA cGMP regulatory compliance exposure. 
  3. Document risks and mitigation strategies in a technical report.  The identified risks and their likelihood, severity, and chance of detection for each risk were documented. A phased approach strategy to mitigate any high risks was designed and presented to the management team.
Results
A review of the high risks items and the mitigation strategies prompted the mangement team to take action. A quality professional was hired to review the internal operations. With on-going technical support, the managment team and the QA professional were able to close all the gaps within four months and successfully passed a major pharmaceutical manufacturer audit to allow American Aerogel to become an approved supplier for their full range of products.