ISO 15378 Consulting, Training & Certification Support

✓ SQS Global supports organizations in preparing for ISO 15378 certification. Certificates are issued by reputable certification bodies in Vietnam and are recognized through BoA and IAF accreditation.

✓ Experienced experts providing consulting, training, and end-to-end implementation support throughout the certification process

✓ Enhance eligibility for supplier qualification, participation in global pharmaceutical supply chains, and expansion into international markets

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ISO 15378 Consulting, Training & Certification Services

✓ SQS Global supports organizations in preparing for ISO 15378 certification. Certificates are issued by reputable certification bodies in Vietnam and are recognized through BoA and IAF accreditation.

✓ Experienced experts providing consulting, training, and end-to-end implementation support throughout the certification process

✓ Enhance eligibility for supplier qualification, participation in global pharmaceutical supply chains, and expansion into international markets

GET A FREE QUOTATION

ISO 15378 certification – Quality management system for pharmaceutical packaging

ISO 15378 is an international standard for quality management systems specifically developed for manufacturers of primary packaging materials that come into direct contact with pharmaceutical products and medical devices. The standard integrates the requirements of ISO 9001 with Good Manufacturing Practices (GMP), helping organizations maintain consistent quality control throughout the design, production and supply of pharmaceutical packaging materials.

Achieving ISO 15378 certification demonstrates an organization’s commitment to quality, regulatory compliance and GMP requirements. It also enhances customer confidence, strengthens supplier approval opportunities and supports participation in the global pharmaceutical supply chain.

Which organizations need ISO 15378 certification?

ISO 15378 is applicable to organizations involved in the manufacture and supply of primary packaging materials for pharmaceutical and healthcare products, including:

Manufacturers of pharmaceutical bottles, vials and closures
Manufacturers of plastic and glass pharmaceutical packaging
Manufacturers of ampoules, syringes and components that come into direct contact with medicinal products
Suppliers of packaging materials for the pharmaceutical and medical device industries
Manufacturers of aluminum foil, blister packs, rubber stoppers and other primary packaging materials for pharmaceuticals
Packaging suppliers serving pharmaceutical, nutraceutical and healthcare product manufacturers
Organizations seeking to comply with GMP requirements, strengthen quality control and enhance credibility within the pharmaceutical sector

Chứng nhận ISO 15378 dành cho doanh nghiệp sản xuất bao bì dược phẩm.

Which organizations need ISO 15378 certification?

ISO 15378 is applicable to organizations involved in the manufacture and supply of primary packaging materials for pharmaceutical and healthcare products, including:

Manufacturers of pharmaceutical bottles, vials and closures
Manufacturers of plastic and glass pharmaceutical packaging
Manufacturers of ampoules, syringes and components that come into direct contact with medicinal products
Suppliers of packaging materials for the pharmaceutical and medical device industries
Manufacturers of aluminum foil, blister packs, rubber stoppers and other primary packaging materials for pharmaceuticals
Packaging suppliers serving pharmaceutical, nutraceutical and healthcare product manufacturers
Organizations seeking to comply with GMP requirements, strengthen quality control and enhance credibility within the pharmaceutical sector

Challenges faced by pharmaceutical packaging manufacturers & the value of ISO 15378

In the pharmaceutical industry, the quality of primary packaging materials has a direct impact on the safety, stability and effectiveness of medicinal products. As a result, pharmaceutical manufacturers increasingly prefer suppliers that operate a quality management system compliant with ISO 15378 and GMP requirements.

Before Implementing ISO 15378	Benefits of ISO 15378 Certification
Difficulty demonstrating quality management capabilities for primary packaging materials in direct contact with medicinal products	Demonstrates a quality management system that meets GMP requirements and international standards
Lack of a dedicated quality management system for pharmaceutical packaging manufacturing	Establishes a quality management system specifically designed for pharmaceutical packaging materials
Challenges in meeting customer and pharmaceutical manufacturer audit requirements	Enhances readiness for supplier audits and customer assessments
Risk of production defects, contamination or quality variations between production batches	Strengthens quality control, product consistency and safety
Limited ability to evaluate and control raw material suppliers	Implements effective supplier qualification, approval and monitoring processes
Difficulty complying with GMP requirements and regulatory expectations for pharmaceutical packaging	Supports compliance with GMP and regulatory requirements applicable to pharmaceutical packaging
Limited opportunities to collaborate with major pharmaceutical manufacturers	Increases confidence among customers, partners and pharmaceutical companies
Challenges in accessing highly regulated markets such as the United States, European Union and Japan	Enhances opportunities to participate in domestic and global pharmaceutical supply chains

Challenges faced by pharmaceutical packaging manufacturers & the value of ISO 15378

In the pharmaceutical industry, the quality of primary packaging materials has a direct impact on the safety, stability and effectiveness of medicinal products. As a result, pharmaceutical manufacturers increasingly prefer suppliers that operate a quality management system compliant with ISO 15378 and GMP requirements.

Before Implementing ISO 15378
Difficulty demonstrating quality management capabilities for primary packaging materials in direct contact with medicinal products
Lack of a dedicated quality management system for pharmaceutical packaging manufacturing
Challenges in meeting customer and pharmaceutical manufacturer audit requirements
Risk of production defects, contamination or quality variations between production batches
Limited ability to evaluate and control raw material suppliers
Difficulty complying with GMP requirements and regulatory expectations for pharmaceutical packaging
Limited opportunities to collaborate with major pharmaceutical manufacturers
Challenges in accessing highly regulated markets such as the United States, European Union and Japan

Benefits of ISO 15378 Certification
Demonstrates a quality management system that meets GMP requirements and international standards
Establishes a quality management system specifically designed for pharmaceutical packaging materials
Enhances readiness for supplier audits and customer assessments
Strengthens quality control, product consistency and safety
Implements effective supplier qualification, approval and monitoring processes
Supports compliance with GMP and regulatory requirements applicable to pharmaceutical packaging
Increases confidence among customers, partners and pharmaceutical companies
Enhances opportunities to participate in domestic and global pharmaceutical supply chains

ISO 15378 Consulting, Training & Certification Support Services at SQS Global

With professional ISO 15378 consulting services, SQS Global partners with businesses throughout the implementation of a quality management system for primary pharmaceutical packaging. Our services cover every stage, from gap assessment, personnel training, and documentation development to internal audits and preparation for certification audits conducted by independent certification bodies.

We help organizations comply with the requirements of ISO 15378 and GMP for primary packaging materials, strengthen quality management capabilities, enhance customer confidence, and expand opportunities within the pharmaceutical supply chain.

ISO 15378 Consulting

Gap assessment & current-state review
ISO 15378 implementation roadmap
Quality management system consulting
Documentation & procedure development

ISO 15378 Training

ISO 15378 awareness training
GMP training for pharmaceutical packaging
Internal auditor training
QA/QC competency development

ISO 15378 Internal Audit

ISO 15378 compliance assessment
Certification readiness review
Nonconformity & risk identification
Corrective action recommendations

ISO 15378 Certification Support

Certification application support
Audit documentation
Audit support
Post-audit corrective support

Standard Transition & Upgrades

Updated standard requirements
Existing system review
Documentation update support
Ongoing compliance assurance

System Maintenance & Improvement

Nonconformity resolution support
Periodic surveillance audits
Future audit preparation
Long-term certification maintenance

ISO 15378 Implementation & Certification Timeline

With the support of SQS Global’s experienced consultants, organizations can significantly reduce the time required to implement the management system, complete the necessary documentation, and prepare for certification audits conducted by an independent certification body.

3 – 6 Months

Small Organizations

(Fewer than 50 employees)

4 – 8 Months

Medium-Sized Organizations

(50 – 200 employees)

6 – 12 Months

Large Organizations

(More than 200 employees)

Factors affecting implementation time

Existing ISO 9001 or GMP implementation status
Maturity of the current quality management system
Facility size and number of production lines
Complexity of pharmaceutical packaging products
Availability of internal project resources
Readiness for certification audits and the time required to address nonconformities.

Thời gian triển khai chứng nhận iso 15378 tùy thuộc vào

ISO 15378 Implementation & Certification Support Costs

The cost of ISO 15378 implementation and certification support depends on several factors, including the size of the organization, number of employees, certification scope, maturity of the existing quality management system, and the on-site audit requirements.

At SQS Global, we begin with a preliminary assessment of your current system before developing a tailored implementation plan and quotation. This approach helps optimize implementation costs, maximize the return on investment, and ensure compliance with ISO 15378 requirements for primary pharmaceutical packaging.

ISO 15378 Implementation & Certification Timeline

With the support of SQS Global’s experienced consultants, organizations can significantly reduce the time required to implement the management system, complete the necessary documentation, and prepare for certification audits conducted by an independent certification body.

3 – 6 Months

Small Organizations

(Fewer than 50 employees)

4 – 8 Months

Medium-Sized Organizations

(50 – 200 employees)

6 – 12 Months

Large Organizations

(More than 200 employees)

Factors affecting implementation time

Existing ISO 9001 or GMP implementation status
Maturity of the current quality management system
Facility size and number of production lines
Complexity of pharmaceutical packaging products
Availability of internal project resources
Readiness for certification audits and the time required to address nonconformities

ISO 15378 certification cost

The cost of ISO 15378 certification depends on several factors, including organizational size, number of employees, certification scope, the maturity of the existing quality management system and the actual audit requirements at the manufacturing facility.

At SQS Global, we conduct an initial assessment of your organization’s current situation before proposing a tailored certification solution and quotation. This approach helps optimize implementation costs, maximize return on investment and ensure compliance with ISO 15378 requirements for pharmaceutical packaging materials.

Why choose ISO 15378 certification services from SQS Global?

Implementing and achieving ISO 15378 certification requires organizations to comply with both quality management system requirements and GMP requirements for pharmaceutical packaging materials. Choosing the right partner can help reduce implementation time, optimize costs and improve the likelihood of achieving certification on the first audit.