The AAHP community recently came together for a Semiannual Membership Meeting on Sept. 14, 2018 in Baltimore. Not only did members network and discuss best practices, they also heard the latest from association leadership and industry experts. AAHP president Mark Land opened the meeting by describing the association as a readm more…

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By Pejman Parhami, Senior Director, Quality Systems, Hyland’s, Inc.   FDA issued many warning letters regarding process validation in 2017 and 2018. were more prominent. Of the warning letters analyzed, about 40% included observations related to process validation. Since 2017, about 30 facilities were found to be noncompliant with respect readm more…

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By Mark Land, AAHP President   Finished product testing is probabilistic and not dispositive of process control; that is why we need process validation. While preparing this article I came across several histories of process validation. One that caught my attention was a book chapter written by Bernard Loftus, formerly readm more…

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By Mark Land, AAHP President   The Homeopathic Pharmacopoeia of the United States says: “Dosage Forms – These, like all other conditions of homeopathic production should be governed by simplicity and usefulness to the physician and patient.”1 This is a good place to start a discussion about process validation for readm more…

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