In June 2015 ICH issued a Q & AÂ Guidance document that complements the Guidance for Industry Active Pharmaceutical Ingredients, ICH Q7. 2000. Since 2000, experience with implementing the guidance has created a need for clarification of various sections. ICH Q7 should be applied in combination with the principles laid down for development and manufacturing in … [Read more...]
Cobwebs On Oxygen Analyzer Foil Trans Ox During FDA Inspection
Trans Ox Citations Result in Warning Letter (June 8, 2015) During a November 13, 2014, through November 20, 2014, inspection of Trans Ox pharmaceutical manufacturing facility at 2543 Morningside Drive, Suite A, West Columbia, South Carolina, an investigator from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing … [Read more...]
Smoke Study Findings Contribute to Mylan Laboratories Warning Letter (8/06/2015)
The following is the second Blog in an on-going series of Blogs obtained from a Warning Letter about Mylan Laboratories, Bangalore, India as well as other Mylan (Agila Specialties Private Ltd.) facilities in India. This second Blog continues the review of the Mylan facilities which were audited February 6-13, 2015 and are located at Plot No. 284-B (19A) Bommasandra Jigani Link … [Read more...]
A REVIEW OF AN EXTENSIVE ENDOTOXIN WARNING LETTER USING THE NEW FDA “ENDOTOXIN” Q&A AS A BACKDROP
GENERAL The following Blog was initially published on October 1, 2012. Teva Parenterals Medicines had received a Warning Letter in December 2009 describing extensive issues with Endotoxin. To obtain more information on this subject, please plan to attend a webinar on Wednesday, September 9 sponsored by Tungsten Shield and COMMENT In … [Read more...]
Quality Metrics and Risk Based Inspections
FDA’s Request for Quality Metrics (New Proposed Guidance July 2015) and Its Basis – The FDA’s Safety and Innovation Act (FDASIA) A Live, Interactive Training Webinar; See: http://www.tungstenshield.com/barry-a-friedman-phd/ Date: Tuesday August 18, 2015 Time: 9:30 - 11:30 AM ET (New York Time) Instructor: Barry … [Read more...]
