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The Injectable Filling Facility From Hell

I know this is a long story, but it is a look inside the “ Walmart of Pharmaceuticals. ” How the everyday products used in hospitals get made...or don’t. "[10/365] Injected" by dissolved is licensed under CC BY-NC-SA 2.0 My second GMP laboratory took me to a sterile injectable manufacturing facility. It was a slight pay increase and I had moved near another site the company. I hope that I might be able to transfer closer to home eventually. I was sorely mistaken. It was the worst experience laboratory work experience of my life. But that's another post. Fast forward six years at the facility was to become my worst validation experience of my life. I was forced into my choice because my two viable opportunities for work were working at this injectable facility close to home or work in downtown Boston in the winter. I chose the former. I also needed to be close to home to go to a training class for a very good cause/family every weekend. When I told my ...

"I'd Like to Help Us Get Through An FDA Audit, But It's Tax Season."

I got hired as a contracted staffer for a remediation project, serving my tour of duty with five other contractors to help with GMP (Good Manufacturing Practices) remediation of a facility. Two hours from home, so it was easy to get to by car, but still got per diem. "Temporary Relief" by A. Jarrett is licensed under CC BY-NC-ND 2.0 The client that was in OTC, over-the-counter, medicines. They mostly did off-patent oral liquids. One of the name brand OTCs to which the facility was fundamental to was first sold a hundred years ago. But the company also partnered with a global generic pharmaceutical company on some valuable branded tablets, that had just come more recently off patent, that were packaged at the facility and were more lucrative. The problem was that the employees did not have a mindset or background in GMP. For most of the facility's history they manufactured products that the FDA only had marginal contact with...

GMP Agent In The Field (And At A Desk)

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