Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) Evaluation

Schiff & Company, Inc. has extensive experience obtaining United States Food and Drug Administration (FDA) approval of manufacturing and distribution sites in the United States and other countries. This includes: bulk processes; pilot, clinical and manufacturing operations; equipment; solid and liquid dosage forms; parenterals; purified water; sterility assurance; support systems; and utilities. The Company can:

• Perform audits to evaluate compliance with regulatory standards
• Prepare standard operating procedures (SOP) for Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP)
• Provide vendor certification
• Conduct training in GMP, quality assurance, and quality control
• Assist in the preparation of responses to warning letters
• Liaise with the FDA

Schiff & Company, Inc. has conducted over 100 GMP, GCP, and GLP audits for drugs, medical devices, biologics, foods, and supplements. Audits have been performed in the United States, Canada, England, Wales, Scotland, Ireland, France, Germany, Italy, Sweden, Poland, China, Taiwan, India, and Japan.