Irbesartan and hydrochlorothiazide combination tablets -Recall

Another voluntary recall of medications used in the treatment of high blood pressure has been issued due to the detection in the active pharmaceutical ingredient of an impurity considered probably carcinogenic to humans by the U.S. Environmental Protection Agency. To...

Outsourcing facilities must be GMP compliant, though…..

Policies for Outsourcing Facilities Posted 10 December 2018 | By Ana Mulero  The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance...

Is your company running short in resources?

Is your company running short of resources for those critical manufacturing, quality & regulatory projects? At Lean Enterprise Consulting we have an excellent hands-on team of engineers, validation specialist, CAPA Specialist, Process Improvement SMEs, regulatory...

Caution- Pen Needles to Inject Medicines: FDA Safety Communication

Caution When Using Pen Needles to Inject Medicines: Today, the U.S. Food and Drug Administration issued a Safety Communication on “Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication.” The FDA is reminding patients, caregivers, and healthcare...