Manufacturers of primary packaging materials for medicinal products

ISO 15378:2017 is a standard for quality management systems (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. The standard identifies the GMP principles and specifies the requirements of Quality Management Systems that apply to the primary packaging of medicines and medical devices. The steps to achieve an ISO 15378 certification include: Getting to know each other and defining goals Pre-audit and project planning meeting Audit - Stage 1 and 2 System evaluation Surveillance audits and recertification

$200