- ISO 15378:2017 standard
indicates requirements for a quality management system where an
organization needs to show its capacity to give primary packaging
materials for medicinal products, which reliably meet customer
requirements, including regulatory
requirements and International Standards relevant to primary packaging
medicinal materials
- An ISO 15378:2017 certificate
with its wholistic way to deal with GMP and quality necessities, is
perceived all through the world. It delivers manufacturers of primary
packaging materials with an appropriate capability for customer approval –
just as improving the organization’s image according to the authorities.
ISO 15378:2017 applies to all manufacturers of packaging materials that
come into direct contact with the medical products. The standard covers
all the typical materials, such as glass, rubber, aluminum, and plastics.
- This ISO standard is currently
lined up with ISO 9001:2015 and has same 10 elements high-level structure.
ISO 15378:2017 determines necessities for a quality management system
where an association needs to exhibit its capacity to deliver primary
packaging materials for medicinal products, which reliably meet customer
requirements, including regulatory prerequisites and International
Standards pertinent to primary packaging materials.
- Objective to upgrade customer
satisfaction through the effective use of the system, including processes
for the development of the system and the confirmation of conformity to
client and material statutory and regulatory necessities.
- The primary packaging material
is identified as the material that is in direct contact with the
measurement structure. With the involvement in Primary packaging standard
which may require any single part of a container closure system which
includes containers, container liners, closures, closure liners, stopper
oversells, etc.
1. What is ISO?
114. What is ISO 20252?
128. What is ISO 18788?
146. What Is IEC 62304?
218. What is ISO 21001?
264. What is PCI DSS?
270. What is ISO 20700?
275. Cost Of Quality
276. 13485
Categories
© 2013 - 2025 . All Rights Reserved.
User questions & answers