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- 24 Nov 2022, 16:59
#5373
List of all Pharmaceutical Validation Guidelines—Quality Management System (QMS)
QMS—Pharmaceutical Guidelines
Deviation
Risk management ICH-Q9
Change control
OOS(Out of Specification)
CAPA (Corrective and Preventive Action)
Handling of Market
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
