YY/T 0567.1-2013Aseptic processing of health care products - Part 1: General requirements (English PDF)

1 Scope

YY/T 0567 provisions of this section concerning the development of the manufacturing process through aseptic processing of health care products, validation and routine control

System processes, procedures and general requirements for the implementation of procedures and guidelines.

This section covers the entire aseptic processing on the general requirements and guidelines. The other part is specified on the filter, lyophilized, line cleaning,

Specific requirements and guidelines for online sterilization and isolation systems of various special/specialized processes and methods.

Note. YY/T 0567 This section does not supersede or replace national regulatory requirements, such as "Good Manufacturing Practices (GMPs)" and/or belonging to a particular

Country or region within the jurisdiction of the pharmaceutical requirements.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein

Member. For undated references, the latest edition (including any amendments) applies to this document.

ISO 9001 quality management system requirements (Qualitymanagementsystems-Requirements)

ISO 11135-1 Sterilization of health care products of ethylene oxide sterilization of medical devices - Part 1 process development, validation and routine control

System Requirements (Sterilizationofhealthcareproducts-Ethyleneoxide-Part 1. Requirementsfordevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices)

ISO 11137-1 Sterilization of health care products developed radiation - Part 1 radiation sterilization of medical devices, validation and routine control

Requirements (Sterilizationofhealthcareproducts-Radiation-Part 1. Requirementsfordevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices)

ISO 11137-2 Radiation Sterilization of health care products - Part 2. Establish sterilization dose (Sterilizationofhealthcare products-Radiation-Part 2. Establishingthesterilizationdose)

Aseptic processing - Part 2 ISO 13408-2 health care products. filters (Asepticprocessingofhealthcareprod- ucts-Part 2. Filtration)

ISO 13408-3 Aseptic processing of health care products - Part 3. lyophilization (Asepticprocessingofhealthcare products-Part 3. Lyophilization)

ISO 13408-4.2005 Aseptic processing of health care products - Part 4. Online Cleaning Technology (Asepticprocessingof healthcareproducts-Part 4. Clean-in-placetechnologies)

Aseptic processing - Part 5 ISO 13408-5 health care products. Online sterilization (Asepticprocessingofhealthcare products-Part 5. Sterilizationinplace)

ISO 13408-6 Aseptic processing of health care products - Part 6. Isolator systems (Asepticprocessingofhealth careproducts-Part 6. Isolatorsystems)

ISO 13485 medical device quality management system for regulatory requirements (Medicaldevices-Qualitymanagement systems-Requirementsforregulatorypurposes)

ISO 14160 sterilization of disposable medical devices containing animal-derived materials, the use of a liquid chemical sterilant sterilization validation and often

Timing Control (Sterilizationofsingle-usemedicaldevicesincorporatingmaterialsofanimalorigin-Validation androutinecontrolofsterilizationbyliquidchemicalsterilants) […]