The Guidance for Industry for Sterile Drugs Produced by Aseptic Processing Released
On September 29, 2004, the FDA issued the final guidance for industry Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice. This guidance replaces the 1987 Guideline on Sterile Drug Products Produced by Aseptic Processing. The guidance recommends "building quality into products" through science-based
facility, equipment, process, and system design for sterile drug manufacture.
Among the sections of the guidance that address risk-based approaches are those relating to key roles played by personnel, design, environmental control, and media fills in an aseptic processing operation. You can access this document in .pdf format by clicking here.
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Aseptic Solutions Offers Presentation and Training Models
Blueprints are useful, but unless you are trained on
reading them, they can sometimes be difficult to understand. However, 3-D
scale models are easy to understand and provide a hands-on training approach
that is pleasant to view. Regardless if the model is for an idea (proposed
fill line, expansion, isolator, etc.), a specific isolator or for an entire Cleanroom, Aseptic Solutions, Inc. provides clients with high-quality 3-D models
for presentation, training or used for identifying areas within your aseptic
processing area that may be susceptible to contamination. We provide
finely crafted acrylic models with the utmost accuracy and attention to
detail. We work closely with your internal resources to identify important
components to be included in order to make your model as realistic and useful as
possible. For more information on our modeling program and to view
pictures, click here.
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Revision
of Annex 1 (Manufacture of sterile medicinal products) to the EU GMP Guide
The revision of Annex 1 to the EU GMP Guide
Volume 4 (http://pharmacos.eudra.org/F2/home.html)
has been adopted by the Ad hoc GMP inspectors Working Group at their meeting on
28-29 April 2003. The amendments only concern section 3 harmonizing where
appropriate the environmental standards for clean rooms laid down in the GMP
Guide with those laid down in international standards (e.g. EN/ISO 14644-1)
together with a minor change to section 20. The remainder of the annex is
unchanged. The Pharmaceutical Committee has adopted the revised version at its
meeting on 15 May 2003 fixing 1 September 2003 as date for coming into
operation. You can view and save the .pdf file by
clicking
here. If you have difficulty opening the .pdf file, click
here to download the latest Acrobat Reader program.
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