cGuff Pharmaceuticals complies with FDA cGMPs and is ISO 9001:2008 certified.

Quality in a service or product is not what you put into it. It is what the client or customer gets out of it. Pharmaceutical Manufacturing

– Peter Drucker

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 accreditations.

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 standards.

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.