BS EN ISO 15378:2017+A1:2024 - Primary Packaging Materials for Medicinal Products

Introducing the latest edition of the essential standard for the pharmaceutical industry: BS EN ISO 15378:2017+A1:2024. This comprehensive document is a must-have for any organization involved in the production of primary packaging materials for medicinal products. It provides particular requirements for the application of ISO 9001:2015, with a specific focus on Good Manufacturing Practice (GMP).

Key Features

• Standard Number: BS EN ISO 15378:2017+A1:2024
• Pages: 96
• Release Date: October 2, 2024
• ISBN: 978 0 539 30731 3
• Status: Standard

Overview

This standard is an indispensable tool for manufacturers of primary packaging materials for medicinal products. It integrates the principles of ISO 9001:2015, ensuring that quality management systems are effectively implemented in line with GMP requirements. This alignment not only enhances product quality but also ensures compliance with regulatory requirements, thereby safeguarding public health.

Why Choose BS EN ISO 15378:2017+A1:2024?

The pharmaceutical industry is one of the most regulated sectors globally, and compliance with standards like BS EN ISO 15378:2017+A1:2024 is crucial. Here are some reasons why this standard is essential for your business:

• Quality Assurance: By adhering to this standard, you ensure that your packaging materials meet the highest quality standards, reducing the risk of contamination and ensuring the safety of medicinal products.
• Regulatory Compliance: Compliance with this standard helps you meet international regulatory requirements, facilitating smoother market access and reducing the risk of non-compliance penalties.
• Process Improvement: The standard provides a framework for continuous improvement, helping you streamline processes, reduce waste, and enhance efficiency.
• Customer Confidence: Demonstrating compliance with this standard can enhance your reputation and build trust with customers, stakeholders, and regulatory bodies.

Detailed Content

The 96-page document is meticulously structured to cover all aspects of primary packaging materials for medicinal products. It includes:

• Introduction to ISO 9001:2015: A detailed explanation of how ISO 9001:2015 principles are applied within the context of GMP for primary packaging materials.
• GMP Requirements: Specific guidelines on how to implement GMP in the production of packaging materials, ensuring product safety and quality.
• Quality Management Systems: Comprehensive coverage of quality management systems tailored for the pharmaceutical packaging industry.
• Risk Management: Strategies for identifying, assessing, and mitigating risks associated with packaging materials.
• Documentation and Record Keeping: Best practices for maintaining accurate and comprehensive records to support compliance and traceability.

Who Should Use This Standard?

This standard is designed for a wide range of professionals in the pharmaceutical industry, including:

• Quality Assurance Managers
• Regulatory Affairs Specialists
• Production Managers
• Compliance Officers
• Packaging Engineers

Stay Ahead with BS EN ISO 15378:2017+A1:2024

In an industry where precision and compliance are paramount, BS EN ISO 15378:2017+A1:2024 provides the guidance and assurance you need to excel. By integrating this standard into your operations, you not only enhance your quality management systems but also position your organization as a leader in the pharmaceutical packaging sector.

Conclusion

BS EN ISO 15378:2017+A1:2024 is more than just a standard; it's a comprehensive guide to achieving excellence in the production of primary packaging materials for medicinal products. With its focus on ISO 9001:2015 and GMP, it ensures that your products meet the highest quality and safety standards, providing peace of mind to both you and your customers.

Invest in the future of your business by adopting BS EN ISO 15378:2017+A1:2024. Ensure compliance, enhance quality, and build trust with this essential standard for the pharmaceutical industry.

BS EN ISO 15378:2017+A1:2024

This standard BS EN ISO 15378:2017+A1:2024 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) is classified in these ICS categories:

• 03.100.70 Management systems
• 11.040.01 Medical equipment in general
• 03.100.70 Management systems
• 11.040.01 Medical equipment in general