ISO 15378:2017 Certification
ISO 15378:2017 specifies requirements for a quality management system applicable to primary packaging materials for medicinal products, incorporating relevant Good Manufacturing Practice requirements. Certification provides independent verification that the management system conforms to applicable quality and regulatory requirements.
What is ISO 15378:2017?
This standard is based on ISO 9001:2015 and includes additional requirements specific to primary packaging materials for medicinal products. It is applicable to organizations involved in the design, manufacture, and supply of such materials, regardless of size or type.
Key Aspects of ISO 15378:2017
- Integration of quality management system requirements with Good Manufacturing Practice
- Control of processes affecting product quality and safety
- Focus on risk management and regulatory compliance
- Traceability and documentation requirements
- Maintenance of consistent product quality
Importance of ISO 15378 Certification
- Demonstrates conformity with quality and Good Manufacturing Practice requirements
- Supports compliance with applicable regulatory requirements
- Enhances control over manufacturing processes for primary packaging materials
- Strengthens confidence of interested parties
- Facilitates alignment with internationally recognized practices
Structure of ISO 15378:2017
The standard follows a structured framework aligned with ISO management system standards:
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
Annexes
Annex A - Clarification of structure, terminology, and concepts
Annex B - Other international standards on quality management systems
Annex C - Good Manufacturing Practice requirements for printed primary packaging materials
Annex D - Guidance on verification, qualification, and validation requirements
ISO Certification Process
The certification process is conducted in accordance with applicable standards and established audit principles, ensuring impartiality, consistency, and transparency.
Step 1 - Inquiry and Application Submission
The process is initiated upon receipt of an inquiry and a completed application form, providing details of the organization activities, scope, and relevant information.
Step 2 - Application Review and Confirmation
The application is reviewed to determine the scope of certification, audit requirements, and necessary arrangements for the certification process.
Step 3 - Stage 1 Audit Planning
An audit plan for Stage 1 is prepared and communicated, defining the scope, objectives, and schedule of the audit.
Step 4 - Stage 1 Audit Conduct
A Stage 1 audit is conducted to evaluate management system documentation, assess site-specific conditions, and determine readiness for Stage 2.
Step 5 - Stage 2 Audit Planning
Following Stage 1, a detailed audit plan for Stage 2 is established for the evaluation of effectiveness.
Step 6 - Stage 2 Audit Conduct
A Stage 2 audit is conducted to assess conformity of the management system with the applicable standard requirements.
Step 7 - Certification Decision and Issue of Certificate
An independent review of audit findings is carried out prior to the certification decision. Upon a positive certification decision, the certificate is issued.