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Compliance Strategies

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 Q8

ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q10 – Pharmaceutical Quality System

Compliance Strategies, Inc. Services

Quality & Compliance Systems

Process Definition, Mapping & Streamlining

Development of Global Systems

System Audits, GXP Audits & FDA Readiness

Due Diligence, Assessment & Vendor Qualification Program

Documentation, Data & Batch Review

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