ISO 15378 Consulting, Training & Certification Services

✓ Certification is listed on the international verification platform IAFCertSearch.org

✓ ISO 15378 certification services supported by SQS Global, with certification recognized through BoA and IAF accreditation frameworks

✓ 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

ISO 15378 Consulting, Training & Certification Services

✓ Certification is listed on the international verification platform IAFCertSearch.org

✓ ISO 15378 certification services supported by SQS Global, with certification recognized through BoA and IAF accreditation frameworks

✓ 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

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.
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 Certification Services at SQS Global

With professional ISO 15378 consulting and certification services, SQS Global supports organizations throughout the entire implementation journey- from initial gap assessment and staff training to documentation development, internal audits, certification audits and ongoing system improvement.

We help organizations comply with GMP requirements for primary pharmaceutical packaging materials, strengthen quality management capabilities and enhance their opportunities to become approved suppliers for pharmaceutical manufacturers and healthcare companies.

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

  • Certification audit execution
  • Compliance verification
  • ISO 15378 certificate issuance
  • Enhanced customer confidence

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 experts, organizations can significantly reduce the time required to establish their management system, prepare documentation and achieve readiness for ISO 15378 certification audits.

doanh nghiệp sản xuất quy mô nhỏ

3 – 6 Months

Small Organizations

(Fewer than 50 employees)

doanh nghiệp quy mô vừa

4 – 8 Months

Medium-Sized Organizations

(50 – 200 employees)

doanh nghiệp quy mô lớn

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
  • Time required to address nonconformities prior to certification
Thời gian triển khai chứng nhận iso 15378 tùy thuộc vào

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.

ISO 15378 implementation & Certification timeline

With the support of SQS Global’s experienced experts, organizations can significantly reduce the time required to establish their management system, prepare documentation and achieve readiness for ISO 15378 certification audits.

doanh nghiệp sản xuất quy mô nhỏ

3 – 6 Months

Small Organizations

(Fewer than 50 employees)

doanh nghiệp quy mô vừa

4 – 8 Months

Medium-Sized Organizations

(50 – 200 employees)

doanh nghiệp quy mô lớn

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
  • Time required to address nonconformities prior to certification
Thời gian triển khai chứng nhận iso 15378 tùy thuộc vào

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.

Expertise & Experience

Experienced consultants in ISO 15378 implementation, training and certification for pharmaceutical packaging manufacturers.

Tư vấn

Professional Support

Support from gap assessment and system development to training, internal audits and certification preparation.

tối ưu chí phí & thời gian

Efficient & Cost-Effective

Tailored implementation plans that help save time, optimize resources and reduce unnecessary costs.

Đánh giá cấp chứng nhận

Certification Readiness

Support in establishing documentation, GMP-compliant processes and systems to enhance certification success.

Other Certification Services Offered by SQS Global

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ISO 13485 Certification

Other Certification Services Offered by SQS Global

Pharmaceutical & Cosmetics Industry

ISO 13485

ISO 13485 Certification