rESOURCES
Some useful references for pharmaceutical & biotechnology quality assurance are provided below:
Quality Systems Regulation (by FDA)
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

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