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BS ISO 15378 : 2006 AMD 17315

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
Superseded date

08-31-2007

Published date

11-23-2012

Foreword
0 Introduction
   0.1 General
   0.2 Process approach
   0.3 Relationship with ISO 9004
   0.4 Compatibility with other management systems
1 Scope
   1.1 General
   1.2 Application
2 Normative references
3 Terms and definitions
4 Quality management system
   4.1 General requirements
   4.2 Documentation requirements
5 Management responsibility
   5.1 Management commitment
   5.2 Customer focus
   5.3 Quality policy
   5.4 Planning
   5.5 Responsibility, authority and communication
   5.6 Management review
6 Resource management
   6.1 Provision of resources
   6.2 Human resources
   6.3 Infrastructure
   6.4 Work environment
   6.5 Maintenance activities
7 Product realization
   7.1 Planning of product realization
   7.2 Customer-related processes
   7.3 Design and development
   7.4 Purchasing
   7.5 Production and service provision
   7.6 Control of monitoring and measuring devices
8 Measurement, analysis and improvement
   8.1 General
   8.2 Monitoring and measurement
   8.3 Control of nonconforming product
   8.4 Analysis of data
   8.5 Improvement
Annex A (normative) GMP requirements for printed primary
        packaging materials
Annex B (informative) Guidance on verification and
        validation requirements for primary packaging
        materials
Annex C (informative) Guidance on risk management for
        primary packaging materials
Bibliography
Index

Defines requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

Committee
CH/212
DevelopmentNote
Supersedes 04/30079743 DC. (06/2006) Renumbered and superseded by BS EN ISO 15378. (08/2007)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 15378:2017 Identical

BS DD264(2007) : 2007 PACKAGING - BRAILLE AND OTHER FORMATS FOR MEDICINAL PRODUCTS

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 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
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 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
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

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