- The production site was inspected, system documents reviewed, and the existing production processes researched. Benchmarked the applied control measures and the requirements in EU GMP Appendix 1 to analyze the gap and therefore generate improvement solutions. - We performed assessments for contamination risks according to the main steps of aseptic production processes. Controlling over the identified medium and high risks on the basis of existing measures was strengthened in order to degrade into low risks. Ultimately, all contamination risks were reduced to acceptable ranges. Referring to expectations and requirements in relevant regulatory guidelines such as PIC/S GMP and ICH, we designed and implemented CCS in view of risk assessment and various aseptic process guidelines.

The professional competence and industrial foresight of AUSTAR CCS execution team was highly recognized by the client for helping them successfully pass WHO PQ. Risk awareness was upgraded, hence their risk assessments were reconsidered. The accumulated data was re-analyzed, and continuous improvement of quality management objectives was achieved.