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Tool for auditing
New edition March 1, 2016 with references to ISO 9001:2015 and ISO 13485:2016.
ICH Q8/Q9/Q10/Q11 with GMP and ISO 9001 references
All 4 Q-guides compiled in a handy format.
FDA, QSIT, Guide to Inspections of Quality Systems
A reproduction of the FDA guide from August 1999
Quality Systems Handbook for Medical Devices
New version with references to ISO 9001:2015 and ISO 13485:2016!
The GMP Handbook - quality systems for the pharmaceutical industry
After thousands of training hours in the Pharmaceutical industry, Anna Lundén has earned a good...
EU GDP Good Distribution Practice of Medicinal Products for Human Use
GMPs for Pharmaceutical sterile production
Collection of the GMPs applicable to sterile production:
US GMPs applicable to Combination products
Collection of the US GMP/QSR regulations applicable to Combination products in a single handy...
GMPs for Pharmaceutical production/API
Collection of the GMPs:
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