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    I.S. EN ISO 15378:2017

    Current The latest, up-to-date edition.

    PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    National Foreword
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Context of the organization
    5 Leadership
    6 Planning
    7 Support
    8 Operation
    9 Performance evaluation
    10 Improvement
    Annex A (informative) - Clarification of new structure,
            terminology and concepts
    Annex B (informative) - Other International Standards
            on quality management and quality management
            systems developed by ISO/TC 176
    Annex C (normative) GMP requirements for printed
            primary packaging materials
    Annex D (informative) Guidance on verification,
            qualification and validation requirements for
            primary packaging materials
    Bibliography
    Alphabetical index of defined terms used in this document

    Abstract - (Show below) - (Hide below)

    Defines requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 10001:2007 Quality management Customer satisfaction Guidelines for codes of conduct for organizations
    IEC 61025:2006 Fault tree analysis (FTA)
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 19011:2011 Guidelines for auditing management systems
    ISO 10015:1999 Quality management Guidelines for training
    ISO 14644-8:2013 Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
    ISO 14698-2:2003 Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
    ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC/ISO 31010:2009 Risk management - Risk assessment techniques
    ISO 31000:2009 Risk management Principles and guidelines
    IEC 61160:2005 Design review
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14644-5:2004 Cleanrooms and associated controlled environments — Part 5: Operations
    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
    ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services
    ISO 10004:2012 Quality management Customer satisfaction Guidelines for monitoring and measuring
    ISO 10014:2006 Quality management Guidelines for realizing financial and economic benefits
    ISO 10005:2005 Quality management systems Guidelines for quality plans
    ISO 10008:2013 Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions
    ISO 10003:2007 Quality management Customer satisfaction Guidelines for dispute resolution external to organizations
    ISO 10006:2003 Quality management systems Guidelines for quality management in projects
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO 14698-1:2003 Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
    ISO 10018:2012 Quality management Guidelines on people involvement and competence
    ISO 10002:2014 Quality management Customer satisfaction Guidelines for complaints handling in organizations
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
    ISO/IEC Guide 73:2002 Risk management Vocabulary Guidelines for use in standards
    ISO/TS 11139:2006 Sterilization of health care products Vocabulary
    ISO/TR 10013:2001 Guidelines for quality management system documentation
    IEC 60300-1:2014 Dependability management - Part 1: Guidance for management and application
    ISO 14001:2015 Environmental management systems — Requirements with guidance for use
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 9001:2015 Quality management systems — Requirements
    ISO 37500:2014 Guidance on outsourcing
    ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
    ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
    ISO 10007:2017 Quality management — Guidelines for configuration management
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