gmp compliance & Validation
Pharmaceutical, Medical Device and Biotechnology manufacturing are characterized by extensive regulatory requirements, which must be addressed all through the organization. AN GROUP has the expertise to provide comprehensive, hands-on GMP Quality Compliance Services and projects to our clients, which includes extensive validation and QMS knowledge.
Methods have to be applied from the initial phase and throughout the entire life cycle of the production facilities to ensure that the products manufactured by the customer always fulfill the approved specifications and regulatory requirements. AN GROUP has the expertise to handle these types of projects, including the subsequent validation process and reference to GAMP. Documentation is established to ensure that a specific process is able to manufacture a product which meets certain specifications and quality characteristics.