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ISO 15378

PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS

Introduction:

ISO 15378 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

ISO 15378 requirements include compliance to ISO 9001 and Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system. Where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.

Good Manufacturing Practice (GMP) is a term that is renowned worldwide for the control and management of manufacturing, testing and final quality control of food / beverage and pharmaceutical goods and their primary packaging. GMP is a set of rules that gives you the affirmation that your item is safe. GMP is responsible for the safety, efficiency, and quality of pharmaceutical products, cosmetic products and edible products and their primary packaging.

The quality approach of GMP guarantees to enable organizations to limit or eliminate instances of contamination, mistakes and errors. This thus shields the customer from purchasing an item, which isn’t effective or even dangerous. It is accepted that GMP is one of the best business tools, which will refine both the compliance and performance of the organization.

Who can apply for ISO 15378 certification?

The certification is availed primarily by companies that are into the design, manufacture, and supply of primary packaging materials for medicinal products. This standard can also be used in other industry sectors when a quality management system with additional requirements over an ISO 9001 system is needed.

ISO 15378 Implementation Points

  • Integration of customer requirements specific to primary packaging materials for medicinal products.
  • Streamlining and Standardizing the manufacturing processes and other business processes
  • Manufacturing Process Control and Monitoring
  • Risk management and Contingency planning
  • Formulating Quality Policy and Objectives
  • Setting up a system for documentation and records.
  • Management information system
  • Business Performance and Sustainability


Benefits of ISO 15378 to Primary Packaging Material Manufacturer after Implementation

  • Entry passport for supply to the customers from pharmaceutical field.
  • Recognition of the certificate and the system by other industry sectors
  • Cost-effectiveness at various stages of the operations of the organizations
  • Improved product safety and warranty management
  • Manufacturing process controls enhance Quality and Productivity
  • Business process streamlining and efficiency improvement
  • Responsibility and Accountability across the organization
  • Better business performance and Enhanced sustainability

Who can apply for ISO 15378 certification?

The certification is availed primarily by companies that are into the design, manufacture, and supply of primary packaging materials for medicinal products. This standard can also be used in other industry sectors when a quality management system with additional requirements over an ISO 9001 system is needed.

ISO 15378 Implementation Points

  • Integration of customer requirements specific to primary packaging materials for medicinal products.
  • Streamlining and Standardizing the manufacturing processes and other business processes
  • Manufacturing Process Control and Monitoring
  • Risk management and Contingency planning
  • Formulating Quality Policy and Objectives
  • Setting up a system for documentation and records.
  • Management information system
  • Business Performance and Sustainability


Benefits of ISO 15378 to Primary Packaging Material Manufacturer after Implementation

  • Entry passport for supply to the customers from pharmaceutical field.
  • Recognition of the certificate and the system by other industry sectors
  • Cost-effectiveness at various stages of the operations of the organizations
  • Improved product safety and warranty management
  • Manufacturing process controls enhance Quality and Productivity
  • Business process streamlining and efficiency improvement
  • Responsibility and Accountability across the organization
  • Better business performance and Enhanced sustainability

How Neozenith helps in the Implementation of ISO 15378

ISO 15378 being a specific standard for primary packaging materials for medicinal products, the required controls and monitoring of the quality management system and actual on-floor practices are very specific and stringent. In such a scenario, the practical, easy, and effective implementation of the system is very essential. Neozenith team with expertise of more than 6 years has supported many clients implement GMP and get ISO 15378 certification.

The ISO 15378 implementation process is described below:

  • Gap analysis, review of the existing Quality Management System. This review is carried out through discussions and verifications of records during visits to the client organization. The pharma customer-specific requirements are taken into consideration to make this activity effective.
  • GMP-based system designing and documentation (Records and Procedures). 100% documentation support is offered by Neozenith. This includes shop floor controls as well as control of documentation and records.
  • Training on GMP and QMS-related requirements
  • Routine assistance and system verification to ensure compliance with the requirements.
  • Internal audit and Management review
  • Certification audit – Stage 1 and Stage 2
  • Submission of the action plan on audit observations
  • Review of reports by the certification authority and awarding the certificate to the organization.