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A Guide to Good Manufacturing Practices, 3rd Edition
Drug and Market Development Publishing, July 2006, Pages: 423
This updated 'Guide to Good Manufacturing Practices' provides pharmaceutical and biological companies of all sizes with assistance in regulatory compliance. The guide examines the new FDA Guidance for Industry documents and a new amendment covering an exemption for investigational drugs in Phase 1 studies. The guide is addressed particularly to smaller sized companies, perhaps those with their first new drug, working on this extra challenge to their capabilities.
Analyzing the contents of the latest versions of the GMP rules laid down by the USA, Canada and Japan, ICH, the EC and WHO, this guide provides pharmaceutical and biological companies of all sizes with assistance in compliance with these rules. The guide is addressed particularly to smaller sized companies, perhaps those with their first new drug, working on this extra challenge to their capabilities.
Questions Answered :
- What drug products are covered by the cGMP regulations?
- At what stage in a drug's development do the cGMP regulations become effective?
- How do we apply these regulations to our manufacturing operations?
- How do we ensure we will pass a cGMP inspection?
Target Audience:
This guide will prove beneficial to the following professionals involved in Pharmaceutical, Biopharmaceutical and Biological development and manufacturing:
- Heads of Manufacturing
- QA, QC
- Regulatory Affairs
- Product & Process Development Scientists
- Manufacturing Supervisory Staff
- QA Auditing Staff
- Validation Experts
- GMP Trainers
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