Smile, You’re On FDA-Camera!

The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections, in light of FDA's new, final "Guidance for Industry on Circumstances That Constitute... Read more

Welcome To The Party Compounders!

The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section... Read more

CAPA – The Untold Story

Try as I might in my consulting work, I can never seem to get away from CAPA.    As much as I would like to help companies prospectively improve their process control;   embrace better quality system integration and document... Read more

UPDATE: Free FDA GMP / QSR Ebooks for IPhone, IPad

This is an UPDATE to a post from May 2010. Please click this link for the original post. On Monday, June 21, Apple released the IPhone OS4.    This update to the Apple IPhone operating system added great new... Read more

Bioanalytical Quality Standard Initiative

Jack Garvey, Founder of Compliance Architects LLC is Co-Chair of the Bioanalytical Quality Standards Initiative.   This initiative, conceived by Synomics Pharma Services, was founded to respond to years of inconsistent guidance and enforcement surrounding bioanalysis in support of... Read more