Pharmaceutical Good Manufacturing Practice Regulation Audits

FDA ensures the quality of pharmaceuticals in the US marketplace through a system of Good Manufacturing Practices (GMPs), a system it takes very seriously. These GMPs provide a standard by which all pharma companies must operate, from handling raw materials, the safety and security of the facilities to testing and validation of equipment and product which together helps to prevent contamination, mix-ups, deviations, failures, and errors. While drug GMPs are a standard across the industry, understanding how to apply them in each setting is unique as each company is able to determine how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures suitable for their business.

EAS consultants offer the best in Drug GMP compliance audits and facilitate an understanding of how to implement quality programs that meet FDA expectations.