Quality & Compliance
We are pleased that McGuff Pharmaceuticals, a FDA reviewed sterile fill manufacturer
enjoys the highest FDA rating, NO ACTION INDICATED.
This comes at a time where FDA vigilance of sterile fill drug manufacturers has
been very aggressive. Our management team has worked very closely with our regulatory
affairs and quality groups to assure the NO ACTIONS INDICATED rating by the FDA
was achieved. We, as anyone in the drug manufacturing industry would imagine, are
very proud of this distinction.
McGuff Pharmaceuticals, Inc. is certified to meet ISO 9001:2008 Standards for Quality Systems Management.
ISO certifies Quality Management Systems and this is the core value of an ISO 9001:2008
certification. A pharmaceutical manufacturing company that has achieved an ISO 9001:2008
certification has achieved the highest-level Quality Management System Certification.
The International Organization
for Standardization, (ISO) Geneva, Switzerland, through independent auditors,
has certified that McGuff Pharmaceuticals meets all requirements of the American
National Standard/ISO 9001:2008 Quality Systems-Model for Quality Assurance in:
- Product Design
- Product Development
- Installation and Servicing
We are proud to demonstrate our technological ability and determination to achieve
Compliance to ISO standards is voluntary and most pharmaceutical manufacturing companies
choose not to become certified because of the added level of Quality System oversight
that FDA current good manufacturing practices (cGMP) do not require. There are different
levels to the ISO 9000 certification. ISO 9001:2008 is considered by many to be
the most difficult to certify against and our certification includes the all-important
Product Design portion of the standard.
Our customers and Outsourcing Sponsors are the direct benefactors of our ISO certification
by assuring, through independent auditors, that McGuff Pharmaceuticals is compliant
to a proven Quality Systems Model. The ability of a pharmaceutical manufacturer
to consistently provide quality products and regulatory compliance is defined by
their ability to manage themselves and their processes.
ISO certification assures our customers that in addition to meeting cGMP requirements
for manufacturing, we will meet the their needs for product design, product development,
production, installation and servicing.
For More Information on Quality & Compliance, Visit:
for Standardization Website
Orion Registrar Inc. Web Site
ANSI-ASQ Accreditation Board
RAAD VOOR Accreditatie
State of California
Drug Manufacturing License