Quality / Regulatory Assurance
All pharmaceutical manufacturers must comply with FDA cGMPs. However, few pharmaceutical
manufacturers voluntarily pursue the ISO 9001 Quality Standard, which is a highly
acclaimed, and difficult-to-reach, Quality Systems achievement. McGuff Pharmaceuticals
is proud to demonstrate our technological ability and determination to achieve both
Our drug products are manufactured using validated processes and equipment while
following exacting standard operating procedures. Our manufacturing and quality
assurance organizations have developed strict controls to ensure product integrity
and accountability. In addition, products are tested and released using formal specifications
and validated analytical methods.
The Quality Assurance organization also maintains an on-site testing laboratory
to ensure that our drug products meet established standards and perform to our high
expectations. We have validated methods for microbiological, biological, chemical
and physical tests and product assays.
Our Quality Assurance organization performs internal audits of operations, as well
as external audits of contract laboratories, raw material and component manufacturers.
These audits assure that our outsourcing partners maintain well-established standard
operating procedures, training, validation, testing systems, and provide a cohesive
regulatory compliance environment that meets McGuff Pharmaceutical's high quality
The Regulatory Affairs organization at McGuff Pharmaceuticals ensures that any operations
to be conducted are designed in compliance with regulatory requirements as specified
by the FDA and/or other regulatory agencies. Ongoing review of operations assures
that projects continue to maintain compliance with the current regulatory environments.
This merging of organization, facilities and regulatory focus allows us to provide
quality products to the health care community.