What's New Unreplied Topics Membership About Us Contact Us Privacy Policy
[Ad]
Forums Blogs Store Members Gallery Directory

Sign In Register

Standards for Assuring Safety & Quality of Pharma Packaging

Started by , Jun 13 2013 02:49 PM
Reply to this Topic
5 Replies

Does anyone know if there is any text or recommendation for assuring safety and quality of packaging for the specific pharma sector?

Share this Topic
Topics you might be interested in
My Perspective on Food Safety: The Role of CEN European Standards How do you feel about the effectiveness of unannounced audits in upholding GFSI standards? Understanding Standards on Food Allergens: Protecting Consumers and Ensuring Safety What are the main differences between BRC and IFS Food standards? How should very small manufacturers address food safety standards with limited resources?
[Ad]

PS 9000:2011
This Standard specifies GMP requirements and guidance within a quality management system (QMS) for suppliers of packaging materials and origination/artwork to the pharmaceutical industry and has been developed through collaboration between the pharmaceutical industry and its suppliers. The Standard provides an important reference text to assist medicinal product manufacturers and their suppliers in their understanding of their respective responsibilities in producing materials of the requisite quality, in order that the final product is fit for purpose.

1 Thank

Maybe also the ISO 1538:2011 can help you :)

Hi Nusa, is ISO 1538:2011 the correct reference number?

Hi, I am verry sorry, I ment ISO 15378

Quite correct Nusa.

 

 

ISO 15378:2011 specifies requirements 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 applicable to primary packaging materials.

 

ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.

Reply to this Topic

Similar Discussion Topics
My Perspective on Food Safety: The Role of CEN European Standards How do you feel about the effectiveness of unannounced audits in upholding GFSI standards? Understanding Standards on Food Allergens: Protecting Consumers and Ensuring Safety What are the main differences between BRC and IFS Food standards? How should very small manufacturers address food safety standards with limited resources? Are Shorts Permitted Under BRC Standards for Packaging Facilities? Are there any food safety standards or guidelines for Freeze Dried Fruits and Vegetables? Documenting non-applicable standards Tesco Audit Standards GFSI standards that include both manufactured and traded goods.
About us

IFSQN is an international networking group for food safety professionals. We connect those interested in food safety to information and to each other. The purpose of the website is to share knowledge, experiences and ideas to make food safer.

All content © Copyright 2021 IFSQN