USFDA Guidance for Pharmaceutical Quality System | USFDA Guidelines for Pharmaceuticals |

'Quality System Approach to Pharmaceutical CGMP Regulations' USFDA Guidance issued on September 2006.
USFDA states that implementing Quality System by this method will ensure implementation of 21CFR Part 210 & Part 211 principles for the Pharmaceutical Manufacturers.
The Guidance defines the requirements for setting up a Quality System at Pharmaceutical Manufacturing Site.
It provides guidance under 4 important points:
1) Management Responsibilities
2) Resources
3) Manufacturing Operations
4) Review
Details have been provided for each point. It also provides details for the Six System Model defined by the USFDA.
This guidance forms the basis of the tripartite ICH Q10 Guidance on 'Pharmaceutical Quality System'.
The content of this presentation has been directly adopted from the USDFA guidance.
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