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MANUFACTURING
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How Clean is Clean in Drug Manufacturing? Part 2
Igor Gorsky Sr. Consultant, ConcordiaValsource, LLC
Introduction
This article is the second part of an article titled, “How Clean is Clean in Drug Manufacturing?” The first article reminded practitioners that Cleaning is an official process, and introduced the term Equipment Cleaning Process (ECP) which will be used in this part as well. In addition, that article described tools that may aid practitioners in the establishment of appropriate residual limits. This article will present a number of tools that may be utilized for the measurement of ECP during all 3 stages of its continuum:
• Development of Cleaning Procedures by Research and Development groups (if it exists)
• Validation of Cleaning Procedures by Technical or Quality groups
• Application of Cleaning Processes by Operations/ Manufacturing organizations.
Submitted: 11/17/2014 Accepted for Publication: 12/01/2014
Gorsky I. How clean is clean in drug manufacturing? Part 2. Am Pharm Rev. 2015;18(1):24-35.
The key to control for any process resides in the understanding of its variability. How much do we know about the variation of our processes or systems and are we in the state of control? These questions require answers to achieve success in the execution of ECP. Understanding, detection, response, and control, from input through output of variation, consumed a focus of the revised FDA Process Validation Guidance1
to Industry (Figure 1).2,3
Stage 1: ECP Design and Development To be highly effective, a Risk
So how does one go about control of variation? To do that one has to enable a Risk Management System.2
Management System needs to be initiated early on during the design and development of ECP. A rigorous application of Risk Management tools during Stage 1 (Process Design Stage) will help the practitioner to assess, understand, and ultimately control the level of variation in systems and processes. Therefore, Critical Quality Attributes and
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