2003N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach
  


  

  
FDA Comment Number : 
  

  
EC32
  



  

  

  



  

  
Submitter : 
  

  
Ms. Katherine Ulman
  

  
Date & Time: 
  

  
06/10/2003 06:06:10
  



  

  
Organization : 
  

  
Dow Corning Healthcare Industries Materials Site
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Examples of effective Dow Corning Business Practices and Policies:

Based on the FDA?s invitation for examples of effective business practices and policies, Dow Corning Healthcare employees identified three areas to highlight. 

The Dow Corning Healthcare Industries Materials Site(HIMS) is located in Hemlock, Michigan, USA and is registered as a drug and device establishment (registration number 1816403).  HIMS operates according to applicable FDA cGMPs and is ISO 9001 certified with BSI, UK.  

HIMS is one of several manufacturing sites owned and operated by Dow Corning Corporation, a specialty chemical company and global leader in silicon-based technology serving many diverse markets.  This provides both challenges (e.g. global systems that need to be monitored/managed at a local level) and opportunities (e.g. a well integrated supply chain) to their operations.  As a result, Healthcare personnel often help develop and set direction for the corporation. 

Areas where we have developed effective quality and regulatory system practices include:

Business Risk Management practices

HIMS has a risk management system in place to support the unique risks and challenges of serving the global health care market both as a raw material and component supplier for medical devices as well as excipients and APIs.  Operating in highly regulated industries with demanding customers and high litigation risks requires an effective and robust process for managing various types of risk.

Our experience with product liability litigation reinforced the need to understand and manage business risk (product, environmental, application, market, etc.) and apply solid management techniques to meet customer needs while generating value for shareholders.

Our process includes the following elements:

? Business Risk Policy 

? Business Risk Management Team that monitors change, reviews products and recommend risk management tactics 

? Risk characterization tools for commercialization process

? Routine process audits

? Product Stewardship experts (part of Responsible Care?  )



Change Control and notification process

The process includes defining, assessing, evaluating (i.e. chemical/physical properties, impurity profiles, functionality, and, if applicable, bioburden), and documenting potential impact of changes made to process and/or materials (raw materials, intermediates and/or finished products). 

Change includes modifications or alterations in materials and/or processes that could potentially impact chemical or physical properties, identity, strength, quality, purity or functionality of finished products. Guidelines include procedures for customer

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 notification and evaluation prior implementation and covers:

? Documentation and control of process, material and system changes

? Reliable process to assess, classifying and manage change

? Process to internally/externally communicate changes



21 CFR 11/Validation program

HIMS is the primary Dow Corning location requiring process validation; however, many ?business systems? are global, thus, electronic systems validation is managed on a global level.  

The site has a validation team leader/ coordinator who provides direction to teams of individuals comprised of operational staff for the process being validated.  Utilizing process owners helps ensure their in-depth understanding of validation activities/processes and aids in completing validation in a more timely, thorough and precise manner.

The HIMS validation program provides for a high level Healthcare business risk-based (addresses both application/use and product quality concerns) validation strategy that includes

? Typical process and documentation protocols/reports

? Risk-based approach to validation of global Dow Corning electronic systems (e.g. SAP, LIMS, bar coding, Product Data Management, etc).

? Process to ensure revalidation considerations when both process and/or system changes are made