PDF file (462 KB)
Opti-Med Controlled Release Labs, Inc., 2002-01-09
"We consider process validation to be an evaluation of the process to determine the optimum parameters to assure blend uniformity by testing a larger number of samples taken at various times during the blending operation from several locations in the blender."
"Your response indicates you believe analysis of a single ingredient (copper) from the vitamin pre-mix is adequate to validate the blend uniformity for Cenogen OB Capsules....."
"You question the need for Blend Uniformity Analysis (BUA). Your Folic Acid containing drugs are subject to the USP monograph that calls for content uniformity testing of Folic Acid Tablets. The requirements of 21 CFR 211.110 call for appropriate sampling of in-process and finished drugs to assure uniformity of the batch....."

PDF file (355 KB)
Cardinal Laboratories, 2001-09-19
"Your firm has not performed blend uniformity studies for the veterinary drug products, as well as the human drug products to assure compliance."

PDF file (366 KB)
Purepac Pharmaceutical Company, 2001-04-09
"The Quality Unit released batches of Phentermine Hydrochloride 37.5 mg Tablets, which failed in-process specifications for blend uniformity. Out-of-specification results, were invalidated due to sampling error, without adequate justification."

PDF file (155 KB)
Stason Pharmaceuticals, Inc., 2000-09-26
"Failure to perform investigations into unexplained discrepancies of a batch or any of its components to meet specifications [211.192]. For example: you did not investigate Out of Specification (OOS) results obtained during blend uniformity testing of the final blend."