YY/T 0567.1-2013 Active
YY/T 0567.1-2013 Aseptic processing of health care products—Part 1:General requirements
Abstract
This part of YY/T 0567 specifies the general requirements and guidelines for the development, validation, and routine control of the manufacturing process of sterile-processed healthcare products.
This part covers the general requirements and guidelines for the entire sterile processing process. Other parts specify the specific requirements and guidelines for various specialized/dedicated processes and methods, such as filtration, freeze-drying, online cleaning, online sterilization, and isolation systems.
Note: This part of YY/T 0567 does not replace or substitute for national regulatory requirements, such as "Good Manufacturing Practices (GMPs)" and/or pharmaceutical requirements that fall under the jurisdiction of specific countries or regions.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0567.1-2013 |
| CCS | Public medical equipment |
| ICS | Integrated disinfection and sterilization |
| Implement Date | 2014-10-01 |