ISO 15378 certification consultants in Saudi Arabia specialize in assisting pharmaceutical packaging material manufacturers in meeting the ISO 15378:2017 standards. These standards specifically outline the requirements for a Quality Management System (QMS) designed for producing primary packaging materials for medicinal products.

Pharmaceutical packaging material manufacturers need to engage skilled ISO 15378 certification consultants. Doing so ensures compliance with global standards, improves product quality, and showcases their dedication to meeting the pharmaceutical industry’s highest quality benchmarks. Get ISO 15378 Certification with the help of Operon Strategist.

ISO 15378 Primary Packaging Material for Medicinal Products

The ISO 15378 Certification serves as a quality assurance measure for primary packaging materials used in the medical product sector, particularly concerning the specific requirements in Saudi Arabia. It builds upon ISO 9001:2008 and aligns with Good Manufacturing Practices (GMP). In 2006, the ISO 15378 standard was introduced, which is process-oriented and draws from the globally recognized ISO 9001 quality standard. It encompasses all the essential GMP elements relevant to primary packaging materials, including batch tracing, risk management, validation, and control of the environment.

What is ISO 15378 Certification?

ISO 15378:2017 standard indicates requirements for a quality management system where an organization needs to show its capacity to give primary packaging materials for medicinal products, which reliably meet customer requirements, including regulatory requirements and International Standards relevant to primary packaging medicinal materials.
An ISO 15378:2017 certificate with its holistic way of dealing with GMP and quality necessities is perceived all through the world. It delivers manufacturers of primary packaging materials with an appropriate capability for customer approval – just as improving the organization’s image according to the authorities. ISO 15378:2017 applies to all manufacturers of packaging materials that come into direct contact with the medical products. The standard covers all the typical materials, such as glass, rubber, aluminum, and plastics.
This ISO standard is currently lined up with ISO 9001:2015 and has same 10 elements high-level structure. ISO 15378:2017 determines necessities for a quality management system where an association needs to exhibit its capacity to deliver primary packaging materials for medicinal products, which reliably meet customer requirements, including regulatory prerequisites and International Standards pertinent to primary packaging materials.
Objective to upgrade customer satisfaction through the effective use of the system, including processes for the development of the system and the confirmation of conformity to client and material statutory and regulatory necessities.
The primary packaging material is identified as the material that is in direct contact with the measurement structure. With the involvement in Primary packaging standard which may require any single part of a container closure system which includes containers, container liners, closures, closure liners, stopper oversells, etc.

Application of ISO 15378

ISO 15378:2017 is an application standard for the structure, manufacture, and supply of primary packaging material for medicinal products.
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 Systems relevant to primary packaging materials for medicinal products.
ISO 15378 can be utilized for quality improvement, training, auditing, and certification.
The ISO 15378 standard is assessed every 5 years.

Looking For ISO 15378 Certification Consultants?

Let’s have a word about your next project

What Are the Benefits of ISO 15378?

ISO 15378 Standard has strategic tools that reduce costs by minimizing waste and manufacturing errors and increasing productivity.
It encourages organizations to get to new markets and encourages free and reasonable worldwide exchange.
The manufacturer of Saudi Arabia or anywhere in the globe can improve their proficiency in production processes by following GMP standards according to ISO 15378 standards.
To relieve your risks particularly identified with product contamination, mix-ups, and errors, and ensure product efficacy and shelf life.
Assurance of quality products to your clients. Upgrade customer satisfaction.
Competitive Advantage over other non-confirmed providers.
The application of risk management helps to reduce errors associated with the product.

What Will Be the Role of Operon Strategist?

Our team will perform various activities like GAP analysis, QMS implementation, and others. After understanding the requirement of ISO 15378, by performing GAP analysis and QMS we can assist you in the creation of documentation and training.

How Will Operon Strategist Help You in ISO 15378?

Operon Strategist helps manufacturers develop quality management systems as per the requirements of ISO 15378. We assist with documentation, training & implementation of the quality system. We help the Primary packaging material manufacturers understand the requirements of ISO 15378 by performing GAP analysis and implementing QMS and GMP requirements as per ISO 15378:2017. As a medical device regulatory consulting company, We support the manufacturers of primary packaging materials for medicinal products to enhance their QMS system by addressing specific requirements to meet the quality objectives as per ISO 15378 certification. Operon Strategist assists the pharmaceutical and medical device industries of Saudi Arabia to assess their suppliers of primary packaging materials and increase overall product quality.

We also provide medical device consultation for India, South Africa, Egypt, the USA, the UK, Costa Rica, Oman, and Iran.

ISO 15378 Certification Consultant- Primary Packaging Regulatory