Med-Health Pharma

Las Vegas, NV

Area: 7,100 m2
Estimated Cost: USD
$10M
This client is a primary
wholesaler of
pharmaceutical products.
A new facility was added to
extend their services to the
repackaging of soliddosages.
PharmEng provided
qualification services and
cGMP expertise to ensure
the new facility was cGMP
compliant within budget
and on schedule.

Responsibilities:

cGMP Gap Analysis

cGMP Review of Processes
FATs & SATs
Commissioning and Qualification
o Validation Master Plan
o Computer Project Plan
o Utility & Equipment Project
Plan
o Cleaning Project Plan
o Commissioning Plan
o Commissioning Execution
o Protocol Development
o Protocol Execution
Quality Assurance
o Quality System
o SOPs Development
o License Applications
Validation Activities