Written By: David Dolgin, Independent Pharma Quality Consultant/Validation Consulting and Training, PSC Biotech®

Imagine the following scenario: 

You are the Plant Engineering Manager for a small to mid-size pharmaceutical company. You have a staff of three or four experienced Plant Engineers who handle the routine care-and-feeding of your site’s equipment and utility systems, and generally keep things running the way they are supposed to.  

Your CEO just bought a new building that will require several new equipment systems and modifications to existing utilities and HVAC.  All the systems planned are like what you have now, but you have concerns about the “bandwidth” of your group.  Can you cover all aspects of the specify/design/install/commission/qualify project steps and still maintain all your other systems and duties? Corporate has not and will not offer your department a wheelbarrow full of cash so, What do you do 

You need to identify the leanest, most efficient way to deliver the on or under cost, on time, and in compliance with the “validate-anything-that moves-and-DO-NOT-move-anything-that-is validated” and current Good Manufacturing Practices.   

Fortunately for you there is a more science-and-engineering based approach, focused on risk and methods of risk assessment that are, as described in the ICH Q91 guidance,  an effort for which “…the level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk”.   

Risk Management

short list of the relevant current guidance documents includes: 

  • U.S. FDA Process Validation: General Principles and Practices” 
  • ICH Q9 Quality Risk Management” 
  • ASTM E 2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”
  • ISPE Baseline Guide 5 Commissioning and Qualification (Second Edition)”

Companies have reported 10%-20% reductions in the totalinstalledcost of new systems when risk-based approaches are expertly applied. To be clear: Quality Risk Management (QRM) is NOT and should not be intended as a cost-saving measure 

If you already use a risk-based process, great!  If not, supplement your staff’s expertise and set-up your risk based process with help from experienced Subject Matter Experts (SMEs) who have done it before. 

Contact PSC® to see how our consultants risk management-based Commissioning and Qualification know-how can save time and cost on your next significant manufacturing facility or system project.  Whether you use your personnel for execution of C&Q or ours, PSC® services will help you realize your project objectives, stay on or below budget and meet your timeline. 

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