Current Good Manufacturing Practice (cGMP) Audits

Overview
Manufacturers of food, drug, and cosmetic products, as well as their suppliers, distributors, and re-packers, must operate according to current Good Manufacturing Practices (cGMP) as a means to ensure that only safe and effective products are placed on the market. cGMP can encompass organizational leadership and personnel, quality systems, the buildings and facilities, equipment, raw materials, production and process controls, packaging and labeling control, holding and distribution, laboratory controls, complaints and recalls, records and reports, and returned & salvaged products. In each instance, cGMP is more than just a collection of written procedures. It’s a set of well-established practices that have been tailored to the specific business operation which are supported by a written quality manual and written operating procedures. Conformance to cGMP requires oversight and surveillance, including internal audits, of the systems that have been put in place to ensure all are working they way they were intended.

Experien Health Sciences offers the following cGMP services:

• Help companies new to cGMP understand their obligations and help them establish the necessary practices and procedures that have been tailored to their business culture and operations.
• Conduct cGMP audits of pharmaceutical excipient manufacturers, including PG USP Distributor Audits.
• Conduct cGMP audits of cosmetic and personal care product manufacturers, including as a representative of brands that exclusively use contract manufacturers.
• Conduct cGMP audits of food manufacturing / processing operations, including suppliers, distributors, and re-packers.
• Oversee / manage the implementation of supplier, distributor, and re-packer audit programs, using agreed-upon audit protocol and schedule.
• Provide input into the design of new facilities that will house cGMP operations, or for upgrading existing facilities.