Quality and Compliance in Pharmaceutical Manufacturing

Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives. Pharmaceutical Manufacturing

– William A. Foster

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
  • Production
  • Installation and Servicing

We are proud to demonstrate our technological ability and determination to achieve this accreditation.

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:

McGuff Pharmaceuticals is ISO 9001 certified
International Organization for Standardization Website

Orion Registered
Orion Registrar Inc. Web Site

McGuff Pharmaceuticals, Inc. is ANAB Accredited
ANSI-ASQ Accreditation Board

RvA C 147 Management Systems
RAAD VOOR Accreditatie

State of California Drug Manufacturing License