This part of YY/T 0567 specifies specific requirements and guidelines for equipment, processes, procedures and procedures for the control and validation of freeze-drying as a sterile processing process. This section does not discuss the physical/chemical purpose of the freeze-drying process.
YY/T 0567.3-2011 Referenced Document
GB/T 19001 Quality Management System Requirements*, 2017-07-01 Update
YY/T 0567.1 Aseptic processing of health care products.Part 1:General requirements*, 2013-10-21 Update
YY/T 0567.4 Aseptic processing of health care products.Part 4:Clean-in-place technologies
YY/T 0567.5 Aseptic processing of health care products.Part 5:Sterilization in place
YY/T 0567.3-2011 history
2011YY/T 0567.3-2011 Aseptic processing of health care products.Part 3:Lyophilization