Tag: GMP

New AAMI TIR48 – QMS for Combination Products

AAMI TIR48, “Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Product,” has just been released.  This new publication helps medical device manufacturers and others effectively implement FDA requirements for CGMP (Current Good Manufacturing Practices) with regards to combination products.

What is a combination product?  It is a product that integrates a medical device with drug delivery, biological products, or other devices.  These types of medical devices are used for therapeutic or diagnostic purposes.  The FDA regulation that applies (21 CFR Part 4) became effective on 7/22/2013.  So this TIR is timely for industry.  Other best practices, guidelines and standards from jurisdictions outside the U.S. are also considered in this publication.

Why did AAMI develop the AAMI TIR48?  Issues surrounding combination products and CGMP operating systems have surfaced as industry needs to meet these new FDA requirements.  The TIR48 gives you the information you need to make informed, risk-based decisions during development, manufacture, premarket regulatory evaluation, and commercialization of your combination medical devices.

What’s included in AAMI TIR48?  The publication starts with a scope clause and then moves directly into how to apply CTMPs in accordance with the FDA’s final rule for combination products (that 21 CFR Part 4 again.)  Clause 3 addresses the issue of transitioning to a “streamlined approach” and all that that entails.  Clause 4 covers the application of design controls and risk management for combination products.  The document is completed by an Annex A on terminology and a 35-item bibliography.

How can you get a copy of AAMI TIR48?  Use an authorized standards distributor like Document Center Inc. to make sure your copy is authorized.  We provide all AAMI standards in both paper format and for pdf download.  Additionally you can include your AAMI standards in our multi-user subscription service, Standards Online.

You can search for and order standards using your browser at www.document-center.com.  Here’s a direct link to order AAMI TIR48.  Want to know more about our subscription service or have other questions?  Contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982.  So make Document Center your Standards Experts!

 

ISO 15378 Updated – Packaging for Medicines

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).

Keeping up with standards is a challenge.  Why not rely on an organization that has been working with standards since 1982.  We have a wide variety of services all geared to making your use of standards more effective.  Make Document Center Inc. your Standards Experts!