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ISO 15378 Certification

Primary Packaging of Medicinal Products.

The ISO 15378 standard applies ISO 9001 to primary packaging materials for medicinal products.

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The ISO 15378 standard specifies particular requirements for the application of ISO 9001, with reference to good manufacturing practice (GMP) requirements, applicable to primary packaging materials for a quality management system (QMS) where an organisation needs to demonstrate the ability to provide primary packaging materials for medicinal products that consistently meet customer and regulatory requirements as well as international best practice.

ISO 15378 is applicable for the design, manufacture and supply of primary packaging materials for medicinal products; the standard is generic and intended to be applicable to any organisation, regardless of its type or size, or the products and services it provides.

ISO 15378 Certification under the AuditOne™ Initiative

The AuditOne™ Initiative seeks to develop a single set of quality standards and audit processes that establish a uniform harmonised standard for the industry. As a result, suppliers will have the opportunity to have one audit that will meet the requirements of multiple customers.

Under AuditOne™, ISO 15378 Certification has been selected as a trusted and recognised primary packaging for medicinal products audit programme, intended to meet the requirements established by F4SS Members in cooperation with Procter & Gamble, Johnson & Johnson, Unilever, L'Oreal and Estee Lauder among other leading consumer goods brands. The process is intended to create a broad and far reaching harmonised quality process for the FMCG/CPG non-foods industry.

We are an approved AuditOne™ certification body, using the technology platform powered by Greenfence. Our knowledge of the medical device, pharmaceutical, medicinal and supplements industries, as well as our packaging, quality and consumer goods experience makes us your approved AuditOne™ certification body of choice, and we’re ready to support your organisation. On our AuditOne™ page you can find more information about the process.

Benefits of ISO 15378 Certification

There are significant benefits in certification to the ISO 15378 primary packaging for medicinal products standard, as it helps reduce or eliminate multiple assessments with the additional benefits of reduction in disruption to the business associated paperwork and costs. Additional benefits include:

  • Demonstration of quality, good manufacturing and safety controls - The ISO 15378 standard testifies to the achievement of the principles of Good Manufacturing Practices and the control of primary packaging items within organisations; very important for the safety of a patient using the drug given its direct contact with the product. The application of Good Manufacturing Practices for pharmaceutical packaging products should ensure that they meet the needs and requirements of the pharmaceutical industry
  • Alignment with ISO 9001:2015 specific to medicinal product packaging - This international standard is an application standard for primary packaging articles that contains the full text of ISO 9001:2015, which allows certified organisations to optimise the implementation of the requirements of ISO 9001 for the manufacture of primary packaging materials for medicinal products
  • Brand protection - Independent ISO 15378 certification helps assure your organisation’s commitment to quality and safety, helping to improve and protect your brand and organisational image, both publicly and with key stakeholders
  • Risk management - ISO 15378 certification is designed to help organisations identify, control and manage risks throughout the ISO 15378 audit process
  • Regulatory compliance - ISO 15378 certification supports your organisation’s efforts to maintain current and anticipated future compliance with applicable statutory and regulatory requirements
  • Customer satisfaction - ISO 15378 certification is designed to help enhance customer satisfaction through the effective application of the QMS, including processes for continual improvement and assurance of conformity to customer requirements.

Choose LR for your ISO 15378 Certification

Experience - We are a market leader in the provision of packaging, consumer goods, safety, quality, pharmaceutical and medical device assessment, certification and training services, and some of the world’s best known organisations choose LR for their assessment and certification needs.

Proven track record - We have high-profile clients in the packaging, food, retail, logistics, storage and distribution sectors.

Packaging, Medical, Pharmaceutical and Quality Assurance Specialists - Our assessors are industry specialists and experts who are matched with your business needs, enabling an effective and robust assessment of your system.

Independence - We are a member of the Lloyd’s Register Foundation, a charity that helps to protect life and property, and also support education, engineering-related research and public engagement.

Global assessment reach – We are a global assurance provider having certified organisations to quality, packaging, medical and pharmaceutical standards in over 120 countries across North America, Latin America, Europe and the Middle East.

AuditOne™- We are an approved AuditOne™ certification body and we are ready to support your organisation’s ISO 15378 certification.

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