BS ISO 15378 : 2006 AMD 17315
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)
31-08-2007
23-11-2012
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 (06/2006) Renumbered and superseded by BS EN ISO 15378.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Superseded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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