The International Standards Organization, (ISO) Geneva, Switzerland, through independent auditors, has certified that McGuff Pharmaceuticals, Inc., (MPI) meets all requirements of the American National Standard/ISO 9001:2000 Quality Systems-Model for Quality Assurance in:

• Product Design

• Product Development

• Production

• Installation and Servicing

MPI is proud to demonstrate our technological ability and determination to achieve this accreditation.

ISO Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose.  International Standards thus contribute to making life simpler, and to increasing the reliability and effectiveness of the goods and services we use.

ISO standards assure that a Japanese IV catheter (Terumo) will fit on a U.S. syringe (Becton-Dickinson) or on a German administration set (Codan) and that and that all single-use  containers for venous blood specimen collection are the same.

ISO certifies Quality Management Systems and this is the core value of an ISO 9001:2000 certification.   A pharmaceutical manufacturing company that has achieved an ISO 9001:2000 certification (such as MPI) has achieved the highest-level Quality Management System Certification. 

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 cGMPs do not require.  There are different levels to the ISO 9000 certification.  ISO 9001:2000 is the most difficult to certify against as it includes the all-important Product Design portion of the Quality System.

MPI customers and Outsourcing Sponsors are the direct benefactors of our ISO certification by assuring, through independent auditors, that MPI 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 MPI customers and Outsourcing Sponsors that we can meet the their needs now and in the future.