Adamson pharma has significant experience implementing both traditional V model and risk-based approaches to Commissioning and qualification (C&Q) activities. Our Risk-based approach assures that elements with the greatest risk to product quality are subjected to the highest level of rigour during C&Q execution. Our criteria for assessment can be tailored to meet your corporate quality mandates but is fundamentally based on that described within ISPE Baseline Guide Volume 5: Commissioning and Qualification, 2nd Edition which encompasses ASTM E2500 and ICHQ9.
Our expertise in C&Q delivery stems from time served experience with the following pharmaceutical and quality engineering manufacturing aspects :
Adamson Pharma can assist Pharmaceutical manufacturers and Healthcare Service Providers increase effectiveness by ensuring good engineering practices are being followed and documented. This in turn increases the degree of quality assurance evident in manufacturing systems. Our validation life cycle services will at all times be made specific to your corporate, system and equipment needs, but essentially can facilitate planning and execution pertaining to: