ГОСТ Р ИСО 15378-2014. Национальный стандарт Российской Федерации. Материалы для первичной упаковки лекарственных средств. Особые требования по применению ИСО 9001:2008 с учетом правил надлежащей производственной практики (GMP)

[1]

ISO 9001:2008 Quality management systems - Requirements

[2]

ISO 9004 Managing for the sustained success of an organization - A quality management approach

[3]

ISO 10007 Quality management systems - Guidelines for configuration management

[4]

ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment

[5]

ISO 11135 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices <1>

[6]

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

[7]

ISO 11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

[8]

ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes

[9]

ISO 14001:2004 Environmental management systems - Requirements with guidance for use

[10]

ISO 14644-4 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up

[11]

ISO 14644-7 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

[12]

ISO 14644-8 Cleanrooms and associated controlled environments - Part 8: Classification of airborne molecular contamination

[13]

ISO 14698-1 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

[14]

ISO 14698-2 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data

[15]

ISO 14937:2009 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

[16]

ISO 14971:2007 Medical devices - Application of risk management to medical devices

[17]

ISO 19011 Guidelines for quality and/or environmental management systems auditing

[18]

ISO/IEC 90003:2004 Software engineering - Guidelines for the application of ISO 9001:2000 to computer software

[19]

ISO/IEC Guide 2 Standardization and related activities - General vocabulary

[20]

ISO/IEC Guide 51:1999 Safety aspects - Guidelines for their inclusion in standards

[21]

IEC 60601-1-4 Medical electrical equipment - Part 1 - 4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

[22]

IEC 60812 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)

[23]

IEC 61025 Fault tree analysis (FTA)

[24]

IEC 61882 Hazard and operability studies (HAZOP studies) - Application guide

[25]

International vocabulary of basic and general terms in metrology (VIM). BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML, 1993

[26]

EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, http://ec.europa.eu/health/documents

[27]

US/FDA Code of Federal Regulations

[28]

GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems, http://www.ispe.org

[29]

PIC/S Guide PE 008-3, Explanatory Notes for Industry on the Preparation of a Site Master File, http://www.picscheme.org/pics.php

[30]

ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, http://www.ich.org

[31]

EU Guidelines to Good Manufacturing Practice for Medical Products for Human and Veterinary Use, Annex 18 Good Manufacturing Practice for Active Pharmaceutical Ingredients Requirements, http://ec.europa.eu/health/documents/

[32]

Global Harmonization Task Force (GHTF) - Study Group 1 (SG1), Document No. N029R15, 2005, http://ghtf.org/

УДК 658.562.014:006.354

ОКС 03.120.10

11.040.01

Т59

ОКСТУ 0025

Ключевые слова: первичные упаковочные материалы, лекарственные средства, система менеджмента качества, ответственность руководства, менеджмент рисков, процессы жизненного цикла продукции