Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)— 82 стр.
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)— 76 стр.
Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements— 30 стр.
BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process— 30 стр.
BS EN ISO 14644-16. Cleanrooms and associated controlled environments. Part 16. Code of practice for improving energy efficiency in cleanrooms and clean air devices— 49 стр.
Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process— 28 стр.
Cleanrooms and associated controlled environments. Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration— 24 стр.
Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004)
