Guide to validation of terminal sterilization process of drugs (GUI-0074): References
- Food and Drugs Act
- Canadian Environmental Protection Act, 1999
- Food and Drug Regulations
- Good manufacturing practices guide for drug products (GUI-0001)
- Guide to validation - Drugs and supporting activities (GUI-0029)
- Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)
- Guidance on parametric release - Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
- Annex 11 to the good manufacturing practices guide: Computerized systems: GUI-0050
- Guidelines for the reduction of ethylene oxide releases from sterilization applications
- Canadian Biosafety Standard, second edition
- Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (EMA)
- Guide to good manufacturing practice for medicinal products annexes, Annex 15: Qualification and validation (PIC/S)
- Guide to good manufacturing practice for medicinal products annexes, Annex 1: Manufacture of sterile products (PIC/S)
- ISO 11137-1: Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (current version)
- ISO 11137-2: Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (current version)
- ISO 11137-3: Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects
- ISO 11137-4: Sterilization of health care products - radiation - Part 4: Guidance on process control (current version)
- ISO 11135: Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (current version)
- ISO TS 13004: Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD (current version)
- ISO 11139: Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards (current version)
- ISO 17665-1: Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (current version)
- PDA Technical Report No. 1: Validation of moist heat sterilization processes: Cycle design, development, qualification and ongoing control (revised 2007, Supplement Vol. 61, No. S-1)
- ICH Quality guidelines