rESOURCES

Some useful references for pharmaceutical & biotechnology quality assurance are provided below:

Quality Systems Regulation (by FDA)

ICH Guidelines on Quality

FDA Office of Regulatory Affairs – Quality Manual

Medical Devices – PMA Quality Manual

FDA Office of Manufacturing Quality

FDA Pharmaceutical Quality/Manufacturing Standards (cGMP)

Quality by Design:  FDA Perspective (Chi-wan Chen)

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q10 – Pharmaceutical Quality System