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Articles/Papers

Funky Fungi: 6 Tips for Mold Containment in Controlled Operation and Storage Environments

Stephen Zulkowski, Associate Quality Scientist – Operations

 
ABSTRACT

Clean, contaminant-free operational settings entail an intelligent approach with regard to environmental monitoring and maintenance. Cleanrooms and cold chain storage areas are designed for controlled operations; thus proper aseptic technique in processes and deliberate attention to detail in cleaning are critical in keeping these rooms, corridors, and temperature-controlled storage facilities compliant with international industry regulations, standards, and best practices. Here are 6 tips to facilitate prevention of mold proliferation in your controlled operation and storage areas…

 

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How to Apply Risk Assessment Techniques to Outsourcing

 Dawn Fernandes, QA

 
ABSTRACT

Over the last decade, as outsourcing has evolved into the rule rather than the exception in the pharmaceutical industry, many lessons have been gleaned by those involved in the day-to-day business of contracted operations.  Experience has shown that it is imperative to assess and qualify a contract organization to ensure it is capable and compliant, but this practice alone rarely ensures that contracted operations will go as smoothly as hoped.  Just as we have used risk assessment and risk management techniques in identifying the critical quality parameters of our products and processes, we can likewise use them in our efforts to identify those factors essential to monitoring and managing outsourced activities.  The application of risk assessment principles to these supporting fundamentals will help us to realize the full benefit of these partnerships, while at the same time ensuring appropriate and adequate oversight of outsourced activities.

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