14/30287226 DC : 0

Superseded

BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)

Available format(s)

Hardcopy , PDF

Superseded date

11-30-2015

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
General
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (normative) - GMP requirements for printed
        primary packaging materials
Annex B (informative) - Guidance on verification,
        qualification and validation requirements
        for primary packaging materials
Annex C (informative) - Relationship between clauses
        of this standard and the high level structure
Bibliography

BS EN ISO 15378

Committee	CH/212
DocumentType	Draft
Pages	84
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 15378:2017

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 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 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
ISO 31000:2009	Risk management Principles and guidelines
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 14698-1:2003	Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
ASTM E 2500 : 2013 : REDLINE	Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
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/TS 11139:2006	Sterilization of health care products Vocabulary
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 9000:2015	Quality management systems — Fundamentals and vocabulary
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
IEC 60601-1-4:1996+AMD1:1999 CSV	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO/IEC Guide 98-3:2008	Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)