ISO 15378 Certification- Quality Management System for Medicinal Packaging

ISO 15378:2017 Certification

ISO 15378:2017 is a standard that outlines the requirements for the production, packaging, and storage of primary packaging materials for medicinal products. The standard is intended to ensure that primary packaging materials are manufactured and handled in a way that meets the stringent requirements of the pharmaceutical industry. It is also intended to ensure that these materials are of the highest quality and meet the specific needs of the pharmaceutical industry.

The standard is designed to help pharmaceutical companies comply with regulatory requirements, such as Good Manufacturing Practice (GMP) for packaging materials, by providing a framework for the development of a QMS that can be audited and certified.

Pharmaceutical packaging standards, such as ISO 15378:2017, are critical for ensuring that packaging materials meet the necessary requirements for the safe and effective storage, transport, and use of medicinal products. These standards cover various aspects of pharmaceutical packaging, including

Quality management system for packaging materials
Risk management for pharmaceutical packaging
Contamination control for medicinal product packaging
Supply chain management for packaging materials
Traceability of pharmaceutical packaging
Quality control for packaging materials in the pharmaceutical industry

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What is ISO 15378:2017 Certification?

ISO 15378:2017 is a standard that specifies requirements for a quality management system (QMS) for manufacturers of primary packaging materials for medicinal products. The standard aims to ensure that packaging materials used in the pharmaceutical industry meet the highest standards of quality, safety, and performance.

Quality Management System for Packaging Materials

A quality management system is a set of policies, procedures, and processes that ensure that products or services meet the necessary quality standards. In the case of packaging materials for medicinal products, a QMS ensures that the materials used are of the highest quality and are produced under controlled conditions.

The QMS must cover all aspects of the manufacturing process, from the selection of raw materials, Labeling and packaging design to the finished product. It must also include procedures for document control, personnel training, equipment calibration, and validation of processes.

Risk Management for Pharmaceutical Packaging

Pharmaceutical packaging must be designed to protect the product from environmental factors, such as temperature, humidity, and light. It must also prevent contamination by microorganisms, particulates, and other foreign matter.

Risk management is the process of identifying potential risks and taking steps to mitigate or eliminate them. In the case of pharmaceutical packaging, risk management involves identifying potential hazards that could compromise the safety or effectiveness of the product and taking steps to prevent them from occurring.

Contamination Control for Medicinal Product Packaging

Contamination control is an essential aspect of pharmaceutical packaging. Contaminants can compromise the safety and efficacy of the product, leading to health risks for patients. Therefore, pharmaceutical packaging must be designed to prevent contamination during the manufacturing process, storage, and transport.

Contamination control measures include maintaining clean manufacturing environments, using sterile materials, and performing regular testing for microorganisms and other contaminants.

Supply Chain Management for Packaging Materials

The supply chain for pharmaceutical packaging materials is complex, involving multiple suppliers, manufacturers, and distributors. Therefore, it is critical to have a robust supply chain management system in place to ensure that the materials used are of the highest quality and meet the necessary regulatory requirements.

Traceability of Pharmaceutical Packaging

Traceability is the ability to track the movement of products and materials through the supply chain. In the case of pharmaceutical packaging, traceability is essential for ensuring that the materials used meet the necessary quality standards and regulatory requirements.

What is ISO 15378:2017 QMS Certification?

ISO 15378:2017 is a Quality Management System (QMS) certification standard that specifies the requirements for the primary packaging materials used in the pharmaceutical industry. The standard focuses on Good Manufacturing Practices (GMP) and ensuring the safety, quality, and consistency of materials used in the production of drugs.

The ISO 15378:2017 standard provides guidelines for the design, development, production, and distribution of packaging materials such as containers, closures, and labels for medicinal products. The standard also includes requirements for risk management, quality control, and documentation.

By obtaining the ISO 15378:2017 certification, pharmaceutical packaging manufacturers can demonstrate their commitment to producing high-quality products that comply with industry regulations and meet customer requirements. The certification can also help organizations improve their operations, reduce waste, and enhance customer satisfaction.

What is the ISO 15378:2017 Guideline?

ISO 15378:2017 is a quality management standard that provides guidelines for the production, control, storage, and distribution of primary packaging materials for medicinal products. This standard is specifically designed for suppliers of packaging materials used in the pharmaceutical industry.

ISO 15378:2017 specifies requirements for the quality management system (QMS) of primary packaging material manufacturers, including

Management responsibilities: The standard outlines the roles and responsibilities of top management in implementing and maintaining the QMS.
Resource management: The standard provides guidelines for managing resources, including personnel, facilities, and equipment.
Product realization: The standard outlines the requirements for ensuring that packaging materials are produced according to the customer’s specifications and regulatory requirements.
Measurement, analysis, and improvement: The standard provides guidelines for monitoring and measuring the effectiveness of the QMS and for continuous improvement.

Step by Step Guide to Get ISO 15378:2017 QMS Certification

To obtain ISO 15378:2017 QMS (Quality Management System) certification, you will need to follow these steps:

Conduct a Gap Analysis: The first step is to conduct a gap analysis to identify the areas where your current quality management system is not compliant with the requirements of the ISO 15378:2017 standard.
Develop an Implementation Plan: Based on the results of the gap analysis, develop a plan to implement the necessary changes to your quality management system to meet the requirements of the standard.
Implement the Changes: Implement the changes identified in the implementation plan, including updating policies, procedures, and processes to meet the requirements of the ISO 15378:2017 standard.
Conduct an Internal Audit: Conduct an internal audit to ensure that your quality management system is compliant with the requirements of the ISO 15378:2017 standard.
Hire an External Auditor: Hire an external auditor who is accredited by a certification body to conduct a certification audit of your quality management system.
Certification Audit: The certification audit will involve a review of your quality management system documentation and processes to ensure that they meet the requirements of the ISO 15378:2017 standard.
Corrective Actions: If any non-conformities are identified during the certification audit, you will need to take corrective action to address them.
Obtain Certification: Once the corrective actions have been completed and verified, the certification body will issue you an ISO 15378:2017 QMS certification.

What are the Benefits of ISO 15378:2017?

ISO 15378:2017 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 can improve their proficiency in production processes by following GMP standards according to ISO 15378:2017 certification standard.

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.

Read our blog: Medical device packaging importance

Application of ISO 15378:2017

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 15378:2017 can be utilized for quality improvement, training, auditing, and certification.
The ISO 15378:2017 certification standard is assessed every 5 years.

How will Operon Strategist Help you in ISO 15378:2017?

Operon Strategist helps manufacturers to develop quality management systems as per the requirements of ISO 15378:2017. We assist with documentation, training & implementation of the quality system. We help the Primary packaging material manufacturers to understand the requirements of ISO 15378:2017 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 15378:2017 certification. Operon Strategist assists the pharmaceutical and medical device industries to assess their suppliers of primary packaging materials and increase overall product quality.

FAQs

What is ISO 15378?

The ISO 15378 – Primary Packaging Materials for Medicinal standard was developed by stakeholders in the pharmaceutical sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products.

What is the ISO for medical devices?

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

What are ISO standards for packaging?

ISO (International Organization for Standardization) has developed a series of standards related to packaging. These standards help ensure the safety, quality, and efficiency of packaging materials and processes. Some of the key ISO standards for packaging include

1. ISO 15378
2. ISO 11607
3. ISO 18916
4. ISO 18602
5. ISO 15394