-
- Available Formats
- Availability
- Priced From ( in USD )
-
-
Secure PDF
Secure PDF Files
Secure PDF files include digital rights management (DRM) software. DRM is included at the request of the publisher, as it helps them protect their copyright by restricting file sharing. In order to read a Secure PDF, you will need to install the FileOpen Plug-In on your computer. The FileOpen Plug-In works with Adobe Reader and other viewers. Visit FileOpen to see the full list.
-
What you can do with a Secure PDF:
- Print
- Search
- Highlight
- Bookmark
- Immediate download
- $515.00
- Add to Cart
-
Secure PDF
Customers Who Bought This Also Bought
-
ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of...
Priced From $515.00 -
ISPE Baseline Guide: Volume 3 - Sterile Product Manufactu...
Priced From $515.00 -
ISPE Baseline Guide: Volume 4 - Water and Steam Systems, ...
Priced From $695.00
About This Item
Full Description
- ICH Q7
- ICH Q9
- GAMP 4
- 21 CFR Part 11
- Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (cGMP)
- FDA Draft Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance
Key features of the Guide include:
- Active Pharmaceutical Ingredient characterization
- Critical process steps
- Potential contamination
- Good Engineering Practice
- Levels of protection
- Critical process parameter
- Critical instruments
- Critical unit operation (new)
- Contamination review (new)
- Design qualification (new)
- Intended patient use (new)
- Direct, indirect, and no impact systems (new)
- Critical and non-critical components (new)
- Facility designation (new)
- Process Analytical Technologies (new)
- process review (new)
- Risk to patient (new)
- Understanding of process (new)
In addition, the revision of this Guide has provided the opportunity to incorporate specific current Good Manufacturing Practices (cGMP) considerations for pharmaceutical manufacturing regions outside the U.S., and has recognized and adopted harmonization work, such as the ICH (International Conference on Harmonisation) Q7 Good Manufacturing Practices for Pharmaceutical Ingredients.