Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)— 76 стр.
Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices— 46 стр.
Cleanrooms and associated controlled environments. Part 2. Specification for testing and monitoring to prove continued compliance with ISO 14644-1— 14 стр.
Cleanrooms and associated controlled environments -- Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration— 28 стр.
Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices— 44 стр.
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices— 48 стр.
Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data— 16 стр.
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)— 94 стр.
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 9001:2015, with reference to good manufacturing practice (GMP)— 94 стр.
