Quality Management System

May I know what is QMS and the file needed under this section.
Does QMS same as Quality System Documents?

For now my company have few of documents which are:

  1. Site Master File
  2. Quality Manual
  3. Validation Mater Plan
  4. Production Master File

Do we need to add any others file under QMS?

Thank you.

QMS-USFDA.pdf (362.9 KB)

Please refer to the attached guidance for the industry issued by USFDA dated September 2006 about the Quality System Approach to Pharmaceutical cGMP Regulations to understand QMS (Quality Management System) principles and how to establish in the pharmaceutical setup.

You will definitely find it interesting.

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