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Understanding ISO15378

Quality Standard for Primary Packaging Materials for Medicinal Products

Essential pharmaceutical and therapeutic packaging materials such as glass, elastic, plastics, aluminium containers/components, foils and films may come in immediate contact with medicinal items therefore specific standards are created so the quality of such devices can conform to the security, viability and dependability of the medical products they may contain. Suppliers of these materials need to meet the certain benchmarks and exhibit consistent level of quality by following a Quality Management Standard (QMS) and adopt good quality practice (GMP) in their production processes.

Photo of pharmaceutical products for primary packaging
ISO 15378:2011 was created in the purpose of providing standards necessary to the production of such materials for producers of pharmaceutical and medicinal packaging materials. These organisations should show their their capacity to constantly meet their customers’ prerequisites, incorporating regulatory requirements and worldwide quality measures relevant to the materials used for such medical products. The ISO 15378:2011  standard incorporates GMP standards and QMS necessities appropriate to achieve production of high quality materials for medical items.

This standard defines the prerequisites for the framework of quality administration in the design, manufacture, distribution, tracking and measurement of a product. It incorporates criteria for the batches and their traceability, control of natural conditions, validation of certain critical methods and risk management.

Any organization or business operations involved in the manufacturing, distribution or managing of such materials for medicinal products may be required to be ISO 15378 certified. Certification is a voluntary activity, yet it is fundamental to maintain its credibility and management of the organization’s suppliers. This certification is valid for 3 years, can be implemented along with other quality standards and internationally recognized so it strengthens a business’ credibility and market competitiveness.

Being ISO 15378 has three major benefits such as it guarantees the products within the package is safe for patients as the materials of the packaging are of high quality, the organization is in compliance with the regulatory provisions within the pharmaceutical industry for medicines and Good Manufacturing Practices are implemented deeming a credible and efficient management system in place.

Obtaining  ISO15378 Certification

ISO consultants are highly recommended to ensure certification in  ISO15378.  QSE’s Ten Step Approach has been proven to help many organizations in manufacturing industry to meet high quality standards in their processes and achieve a credible and competitive status by obtaining quality standard certifications. With more than 20 years of experience in providing proper consulting, training and auditing, and the simplicity of approach, they provide superior benefits such as reduced documentation, sustainable implementation, real world application, improved quality, better efficiency, increased productivity and bottom line improvement. Contact a QSE Consultant through their website or call 770 – 518 – 9967770 – 518 – 9967 now.

Need Certification?

Quality System Enhancement has been a leader in global certification services for the past 30 years. With more than 800 companies successfully certified, our proprietary 10-Step Approach™ to certification offers an unmatched 100% success rate for our clients.

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