Baseline Guide Volume 1, 2nd Edition: Active Pharmaceutical Ingredients Revision to Bulk Pharmaceutical Chemicals

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Published: June 2007

Pages: 188
Table of Contents ( 73 KB)
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This revised Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, (originally entitled Bulk Pharmaceutical Chemicals). The ISPE API Baseline Guide also incorporates and builds on new regulations and guidance, such as:

  • 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  • FDA Draft Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance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.

Last Update: 29 April 2013

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Receive White Paper with Purchase

With the purchase of the API Guide, you will also receive a white paper, Briefly Exposed (Briefly Open), by Stan Newberger and Dr. Trish Melton. This white paper expands and clarifies a new concept introduced in the Guide. This new concept, Briefly Exposed, allows manufacturers another degree of freedom in operations. They will be able to briefly open their processes for various reasons (sampling, adding ingredients, other) for short time periods and under certain circumstances and to apply the most appropriate levels of protection (Level I, II, or III) based on risk-mitigation. An assessment of the risk to the API and ultimately to the patient is an appropriate method for manufacturers to establish what those circumstances are.