ISO 15378 Primary Packaging Materials for Medicinal Products Seminar

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.

This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. It is applicable to any organization, regardless of size, which are involved in manufacturing glass, plastic, rubber, aluminum and other materials used for medicinal packaging.

Why ISO 15378?

When you certify your operation against the ISO 15378 standard, you:

• Comply to applicable statutory and regulatory requirements.
• Ensure the design, manufacture and supply of primary packaging materials meet the needs and requirements of the standard
• Mitigate your risks especially related to contamination, mix-ups and manufacturing errors
• Improve efficiency and cost-effectiveness in your operation
• Gain competitive advantage in the industry

Objectives:

At the end of the seminar, you will be able to understand:

• the development of an International Standard for Pharmaceutical Packaging Materials
• the key requirements of ISO 15378
• the two (2) key annexes
• how your organization could benefit from ISO 15378

Fee: RM 100 (not inclusive 6% GST)

For more information on the seminar, please contact SGS Academy at +603 2095 9200 or email cbe.my@sgs.com