Our approach to compliance is based on a thorough understanding of the requirements and expectations of the governing bodies. Inherent in the expectations of the regulatory bodies is the proper interpretation and application of the GxP Requirements to each system or subsystem, being assured that it can consistently meet or exceed requirements for product safety, efficacy, and quality.
There is not one specific way to achieve this, but the solution applied must show that the regulatory expectations have been satisfied. The penalties can be very high for not complying with the regulation and expectations, not having necessary testing and documentation, and in turn not having adequate assurance that the process produces a product meeting specifications and quality attributes.
The GxP requirements in the areas of GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), GLP (Good Laboratory Practice), and GDP (Good Distribution Practice) are becoming global. Requirements of regulation come from guidance of the FDA and such agencies as the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, the European Medical E Agency, and the Japanese Ministry of Health, Labour, and Welfare. We stay abreast of the agency expectations in the United States and Internationally and the guidance of organizations such as GAMP Forum, ICH, ISO, and ISPE that establish the industry standards.