GMPs

Jan 21, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.
Jan 01, 2016
Pharmaceutical Technology
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
Dec 10, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.
Dec 02, 2015
Pharmaceutical Technology
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.
Nov 17, 2015
By Pharmaceutical Technology Editors
Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.
Oct 02, 2015
Pharmaceutical Technology
An integrated approach can improve the efficiency of cleaning validation studies.
Oct 02, 2015
Pharmaceutical Technology
Managing change and overcoming employee resistance and fear requires a proactive approach.
Sep 16, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
Sep 16, 2015
Equipment and Processing Report
Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.
Sep 08, 2015
Pharmaceutical Technology
A study of recent inspection observations allows for baseline trending and continuous improvement.
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