ГОСТ Р ИСО 15378-2017. Национальный стандарт Российской Федерации. Первичные упаковочные материалы для лекарственных средств. Частные требования по применению ИСО 9001:2008 с учетом надлежащей производственной практики (GMP)

[1]

ИСО 9001

Quality management systems - Requirements <1>

[2]

ИСО 9004

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

[3]

ИСО 10007

Quality management systems - Guidelines for configuration management

[4]

ИСО 10012

Measurement management systems - Requirements for measurement processes and measuring equipment

[5]

ИСО 11135

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

[6]

ИСО 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]

ИСО 11137-2

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

[8]

ИСО/TS 11139

Sterilization of health care products - Vocabulary

[9]

ИСО 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

[10]

ИСО 14001:2004

Environmental management systems - Requirements with guidance for use

[11]

ИСО 14644-1

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration

[12]

ИСО 14644-2

Cleanrooms and associated controlled environments - Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ИСО 14644-1

[13]

ИСО 14644-3

Cleanrooms and associated controlled environments - Part 3: Test methods

[14]

ИСО 14644-4

Cleanrooms and associated controlled environments - Part 4: Design

[15]

ИСО 14644-5

Cleanrooms and associated controlled environments - Part 5: Operations construction and start-up

[16]

ИСО 14644-7

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

[17]

ИСО 14644-8

Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)

[18]

ИСО 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

[19]

ИСО 14971

Medical devices - Application of risk management to medical devices

[20]

ИСО 19011

Guidelines for auditing management systems

[21]

ИСО 31000

Risk management - Principles and guidelines

[22]

IEC 31010

Risk management - Risk assessment techniques

[23]

ИСО/IEC 90003

Software engineering - Guidelines for the application of ИСО 9001:2008 to computer software Under revision

[24]

ИСО/IEC Guide 2

Standardization and related activities - General vocabulary

[25]

ИСО Guide 73

Risk management - Vocabulary

[26]

ИСО/IEC Guide 99:2007

International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

[27]

IEC 60601-1

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

[28]

IEC 60812

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

[29]

IEC 61025

Fault tree analysis (FTA)

[30]

IEC 61882

Hazard and operability studies (HAZOP studies) - Application guide

[31]

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

[32]

US/FDA Code of Federal Regulations. Title 21, Part 11, www.fda.gov

[33]

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

[34]

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

[35]

ICH Q9. Quality risk management, http://www.ich.org

[36]

ICH Q10. Pharmaceutical quality system, http://www.ich.org

[37]

EU Guidelines to Good Manufacturing Practice for Medical Products for Human and Veterinary Use. Volume 4, Annex 15 Qualification and Validation and Annex 18 Good Manufacturing Practice for Active Pharmaceutical Ingredients Requirements, http://ec.europa. eu/health/documents/

[38]

The Pharmaceutical Quality Group, http://www.pqg.org/pharma/

[39]

ASTM E 2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

[40]

Приказ Минпромторга России от 14 июня 2013 г. N 916 "Об утверждении правил надлежащей производственной практики"