In addition to ISO 9001, this document specifies 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.
In this document the term “if appropriate” is used several times. When a requirement is qualified by this
phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise.
This document is an application standard for the design, manufacture and supply of primary packaging
materials for medicinal products.
| File Size : | 1
file
, 2.1 MB |
| ISBN(s) : | 9780539307313 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 94 |
| Published : | 09/30/2024 |
