QA

详细说明

      Our quality assurance system is set against ICH Q7a, which stands for stringent quality management system enabling Sinomega products to meet the pharmaceutical quality standards. Sinomega always give the first priority to the QA/QC in all our operations. Quality assurance and quality control goes through from raw material, in-process and finished product release, which is thoroughly performed in each process step by responsible department and the qualified personnel. Our quality system keeps improvement and perfection to ensure the product quality, which enables us to deliver the quality product to our respected customers.
  1.Critical raw material supplier audit.
  2.Contract laboratory audit.
  3.Continuous improvement of the quality management system.
  4.Make quality standards and specification for raw material, in-process products and finished products.
  5.Regular internal quality audit and self-inspection to compliance with the cGMP (current Good Manufacturing Practice).
  6.Maintain and improve the standard operating procedures (SOPs).
  7.Validate each production and testing process.
  8.Maintain full traceability records of each Sinomega product manufactured at our facility.
  9.On-site Q/A monitor and control in each process step.
  10.Organize and perform on-time personnel training as per training plan.
  11.Entertain clients’ audition and visits.
  12.Process client complains and comments, keep visitation records and deliver quality- related information and feed backs.