| |
|
Services
Provided to the Biotechnology and
Pharmaceutical Industries
QAM is the world’s largest provider of quality assurance/quality
control services to owners of biotechnology, pharmaceutical,
and cosmetics manufacturing facilities. From our nine US and
two overseas offices, more than 150 certified QA technicians,
inspectors and engineers supply testing, documentation, data
tracking and statistical
controls. We maintain an unparalleled inventory of advanced
inspection and analytical equipment and can respond to projects
in the United States, Puerto Rico, the Pacific Rim, Europe,
and Latin America.
QAM has earned worldwide recognition as the leader in independent
QA/QC inspection and testing of biotechnology and pharmaceutical
process facilities. Our staff has extensive background and
up-to-date training in current Good Manufacturing Practices
(cGMP), as well as the latest industry codes and standards.
Value added benefits through our biopharm services include:
- Knowledge of FDA regulatory
requirements
- Extensive industry experience
in order to successfully carry out any size project
- Value added services that
increase efficiencies and reduce operating costs
- Strategic alliances with
key validation companies that enable us to efficiently
and accurately complete validation support of any
project, from construction through FDA approval
|
We offer the following biopharm
installation and validation services:
|
- Specification review
- Vendor audits/ source inspections
- FDA validation assistance
- SOP development
- Borescope/ weld inspection
- cGMP documentation
- Weld inspection / welder
certification
- Slope verification
- Factory acceptance testing
(FATs)
|
|
|
