GMP Audit Checklist for Pharmaceutical and API Manufacturers

This convenient document contains in-depth background information about planning and carrying out audits. The checklist with more than 700 questions tipically asked during audits or inspections, is arranged by subject-matter. Both parts of the book prepare you in an excellent way for audits (internally and externally) and inspections. The section of the corresponding GMP guidelines is quoted next to each question. This way the background of the question and possible answers can be easily researched in the original guidelines and laws. The information sources include the 21 CFR 210/211/11 as well as the EU-GMP-Guide Parts I and II.
The GMP Audit Checklist works great for both sides - the auditor and the inspected company and facilitates and efficient preparation for - an audit or an inspection to come - self-inspections - your own GMP audit of suppliers and subcontractors.