Jump to content

  • Quick Navigation
Photo

A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packa


  • You cannot start a new topic
  • Please log in to reply
1 reply to this topic

#1 Simon

Simon

    Grade - FIFSQN

  • IFSQN Admin
  • 11,390 posts
  • 1018 thanks
222
Excellent

  • United Kingdom
    United Kingdom
  • Gender:Male
  • Location:Manchester
  • Interests:Life, Family, Running, Cycling, Manager of a Football Team, Work, Watching Sport, The Internet, Food, Real Ale and Sleeping...

Posted 08 May 2011 - 09:39 AM

File Name: A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials
File Submitter: Simon
File Submitted: 08 May 2011
File Category: Guidance Documents

This PS 9004 guide is copyright protected by IQA/Pharmaceutical Quality Group(PQG). This guide aims to assist suppliers of pharmaceutical packaging materials to understand and implement the Quality Management System (QMS) of ISO 9001 and the application standard of PS 9000. It supplements the following documents:

• ISO 9001 which specifies the requirements of the international QMS standard
• ISO 9004 gives guidance on ISO 9001
• PS 9000 is an application standard written by the PQG for suppliers of pharmaceutical packaging materials that integrates ISO 9001 and ISO 9004 together with additional Good Manufacturing Practices (GMP) requirements particular to these suppliers

Companies complying with PS 9000 will comply with ISO 9001 and also the additional GMP requirements endorsed by the highly regulated pharmaceutical industry

Click here to download this file
  • 0

Best Regards,

Simon Timperley
IFSQN Administrator
 
hand-pointing-down.gif

Need food safety advice?
Relax, you've come to the right place…

The IFSQN is a helpful network of volunteers providing answers and support. Check out the forums and get free advice from the experts on food safety management systems and a wide range of food safety topics.

 
We could make a huge list of rules, terms and conditions, but you probably wouldn’t read them.

All that we ask is that you observe the following:


1. No spam, profanity, pornography, trolling or personal attacks

2. Topics and posts should be “on topic” and related to site content
3. No (unpaid) advertising
4. You may have one account on the board at any one time
5. Enjoy your stay!


#2 saguym

saguym

    Grade - AIFSQN

  • IFSQN Associate
  • 27 posts
  • 3 thanks
0
Neutral

  • Israel
    Israel
  • Gender:Male
  • Interests:Fountain Pens, Music, Traveling

Posted 08 May 2011 - 11:24 PM

File Name: A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials
File Submitter: Simon
File Submitted: 08 May 2011
File Category: Guidance Documents

This PS 9004 guide is copyright protected by IQA/Pharmaceutical Quality Group(PQG). This guide aims to assist suppliers of pharmaceutical packaging materials to understand and implement the Quality Management System (QMS) of ISO 9001 and the application standard of PS 9000. It supplements the following documents:

• ISO 9001 which specifies the requirements of the international QMS standard
• ISO 9004 gives guidance on ISO 9001
• PS 9000 is an application standard written by the PQG for suppliers of pharmaceutical packaging materials that integrates ISO 9001 and ISO 9004 together with additional Good Manufacturing Practices (GMP) requirements particular to these suppliers

Companies complying with PS 9000 will comply with ISO 9001 and also the additional GMP requirements endorsed by the highly regulated pharmaceutical industry

Click here to download this file


Simon,
As far as I know the ISO 15378 (2006), is actually the GMP requirments for primary packaging materials for medicinal products, with particular requirments for the application of ISO 9001.
Are ther any links between PS 9000 and ISO 15378 ?

saguym
  • 0




0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users