What is ISO 15378 Certification?

ISO 15378:2017 specifies the requirements for a quality management system for organizations that manufacture primary packaging materials for medicinal products. It integrates Good Manufacturing Practices (GMP) with ISO 9001:2015 principles to ensure quality, safety, and traceability. 

This certification is applicable to all manufacturers of packaging materials that come into direct contact with medicinal products, such as glass, plastics, rubber, and aluminum. It ensures compliance with both international standards and Brazilian regulatory requirements, boosting market acceptance and customer trust. 

Operon Strategist provides end-to-end consulting services for ISO 15378 Certification in Brazil, ensuring compliance with global quality standards and regulatory requirements for primary packaging materials in the pharmaceutical and medical device industries. With our expertise, we help manufacturers implement GMP-based systems and achieve certification successfully. 

Let's Grow Your Business Together

Let’s have word about your next project

Key Requirements of ISO 15378 Certification

To achieve certification, organizations must comply with: 

  • Good Manufacturing Practices (GMP): Maintain consistent quality and prevent contamination. 
  • Risk Management: Identify and mitigate risks in packaging and production processes. 
  • Documentation Control: Ensure accurate, traceable records for compliance. 
  • Supplier Management: Work only with suppliers meeting ISO 15378 standards.
ISO 15378 certification for primary packaging

Benefits of ISO 15378 Certification in Brazil

  • Assures the quality and safety of primary packaging materials. 
  • Reduces risks of contamination, errors, and mix-ups. 
  • Increases market access and competitiveness in Brazil and globally. 
  • Improves customer satisfaction and regulatory compliance. 
  • Supports cost reduction through process efficiency and waste minimization.

ISO Training Services for Certification Success

We offer a range of ISO training services to support companies in their certification journey. Our training solutions include:

  • ISO 15378 Training: Comprehensive training to help your team understand the requirements and implementation of ISO 15378.

  • ISO 13485 Certification Training: A detailed course to guide companies through the quality management system requirements for medical devices.

  • ISO 13485 Internal Auditor Course: Equip your team with the skills to perform internal audits and ensure compliance with ISO 13485.

Training is crucial to maintain standards and facilitate a smooth certification process.

Application of ISO 15378

  1. ISO 15378:2017 is an application standard for the structure, manufacture and supply of primary packaging material for the medicinal product.
  2. It is additionally appropriate for certification purposes of primary packaging material for medicinal products in pharmaceuticals and medical device industries. This primary packaging standard discovers Good manufacturing practice (GMP) standards and Quality Management System relevant to primary packaging materials for medicinal products.
  3. ISO 15378 can be utilized for quality improvement, training, auditing and certification.
  4. The ISO 15378 standard is assessed at every 5 years.

Role of Operon Strategist in ISO 15378 Certification

As an expert medical device and pharmaceutical packaging consultant, Operon Strategist helps manufacturers in Brazil with: 

  • GAP Analysis of existing systems. 
  • QMS Implementation aligned with ISO 15378:2017 and GMP. 
  • Documentation Support (procedures, manuals, records). 
  • Training Programs for staff and internal auditors. 
  • Audit Preparedness to ensure smooth certification. 

We guide you through every step of certification, ensuring timely deliverables and error-free compliance. 

We also provide medical device consultation for India, Saudi Arabia, Algeria, the USA, the UK, South Africa, Oman, Iran & Egypt. Feel free to contact us.

FAQs

What is ISO 15378 certification?

ISO 15378 is an international standard that specifies Good Manufacturing Practices (GMP) for primary packaging materials used in medicinal products. It ensures quality, safety, and regulatory compliance in pharmaceutical packaging.

Who needs ISO 15378 certification?

ISO 15378 certification is essential for manufacturers of primary packaging materials such as glass, plastic, rubber, and aluminum used in the pharmaceutical and medical device industries.

How does ISO 15378 help with GMP compliance?

ISO 15378 incorporates GMP principles, ensuring that primary packaging materials meet pharmaceutical industry quality and safety requirements while complying with international regulations.