Published Articles
Root Cause Analysis and Deviations
Q. What is a deviation & do all deviations need a root cause analysis? A. A deviation is when there is a failure to follow the instructions guiding the performance...
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Published Articles
CDMO’s & Contract Manufacturers
What is a CDMO? A CDMO is a Contract Development and Manufacturing Organization. These are companies in the pharmaceutical, biotechnology, and medical device industries that provide outsourced services to other...
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Published Articles
Standard Operating Procedure (SOPs)
The amount of quality assurance detail included in Standard Operating Procedures (SOP) may help a company stay QA compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, Inc....
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Published Articles
Extractables and Leachables
Q: I am a regulatory professional working for a small company with a product in the early stages of development. Can you tell me when I need to submit the...
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Published Articles
FDA Inspection Procedure
Q: Companies have made a lot of operational changes to accommodate working through the pandemic. What changes do you think will become permanent in FDA inspection procedure as a result...
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Published Articles
Quality Risk Management Guidelines
Q. I have heard that the International Council for Harmonization’s (ICH’s) Q9 Quality Risk Management is being revised. Do you know what the industry can expect to see with the...
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