ISO 15378, “Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP),” has just been updated. The new 3rd Edition cancels and replaces the previous 2nd Edition from 2011. This standard provides medicinal product manufacturers and packagers with specific requirements for safe packaging to meet GMP principles.
The standard has a couple of features you’ll find useful. First, since it is a way to make sure you’re meeting the ISO 9001 requirements, various clauses are reprinted in whole, notated by a box around the text. Also, text that specifically contains GMP information regarding primary packaging materials is in intalics. So you’ll always be able to visually understand what information pertains to each resource.
Now for the big question all ISO 15378 users have: What are the changes in the ISO 15378:2015 Edition? Here’s the guidance provided by the committee:
- This new edition includes requirements for risk management.
- There is an extensive revision regarding verification, qualification and validation requirements for primary packaging materials.
- The requirements for infrastructure, work environment, maintenance and cleaning activities have been revised. Also the requirements for customer communication, control of production and service provision and batch release have been modified.
Of course, ISO 9001 has recently been updated and other referenced documents are currently in the revision cycle as well (ISO 14644-1 and ISO 14644-2). So there are sure to be further changes to this standard in the future. But for now, those of you using this document will be glad of the additional guidance it provides, particularly in the area of risk management.
So you’ll need a copy and you’ll want to make sure that you get it from an authorized reseller like Document Center Inc. It’s easy to search and order standards at our webstore, www.document-center.com. Here’s the direct link for the ISO 15378. Want more information on the standard or how to include it in our enterprise solution, the Standards Online multiuser subscription service? Just get in touch with our staff for more information. You can reach them by phone (650-591-7600) or email (info@document-center.com).
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