PharmD Info

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