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List of all Pharmaceutical Validation Guidelines—Quality Management System (QMS)

QMS—Pharmaceutical Guidelines

Deviation

  • Deviation handling and quality risk management, WHO-July-2013
  • ICH Q10 (international conference on harmonization) PQS-10)
  • 21 CFR 211,100 (Deviation description)
  • PICS-2013-Guid to good manufacturing practice for medical product.

Risk management ICH-Q9

  • ICH Q9 (Quality Risk Management- Step 4) November 9, 2005
  • WHO TRS no.961-2013-WHO guideline in quality risk management
  • PICS PE-009-15 MAY-2021

Change control

  • Central drugs standard control organization, CDSCO/PAC1108
  • ICH-Q10- pharmaceutical quality system
  • WHO TRS NO-992,2015 annex-3-guideline on good manufacturing practice
  • Guideline for industrial-QS guide (change control and CAPA)
  • 21 CFR 211.100 (Deviation)

OOS(Out of Specification)

  • USFDA_2022 -Investigating Out-of-Specification (OOS)Test Results for Pharmaceutical Production
  • Guidance for Industry-May 2022

CAPA (Corrective and Preventive Action)

  • FDA- investigation to determination of root cause relating to product, processes, and the quality system
  • ICH Q10 (international conference on harmonization) PQS-10)
  • FDA-sept-2006 pharmaceutical CGMP regulations for change control, CAPA, risk assessments.

Handling of Market

  • Complaint-schedule-M Drug and cosmetic act-1940 & drug and cosmetic rules 1945,India
  • 21code of federal regulation, part-211

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