Top reasons for invalidating oos results

07 Dec

PDF file (240 KB) Searle, Ltd., 2002-12-27 "During the validation of the manufacturing process for Plaquenil, two of the validation lots had out of specification results for the hardness test.

However, in your validation report you concluded that lots xxxxx were in compliance because low hardness result tablets pass friability and high hardness result tablets pass dissolution testing.

Q: Does a QP from an EU Member State who is appointed by the Member States Main Pharmaceutical Inspectorate as a QP and is chemist and not a pharmacist can move to Germany and still carry out duties of QP?

A: Although the educational background would not be considered sufficient by the various local authorities in Germany to be initially accepted as a QP, a Chemist would be accepted once he/she is registered as a QP in another Member State.

The EU requirements as defined in these Directives have to be transferred to national law in each EU Member State.

Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3."Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," the FDA said in the letter to KGV ---------------------------------- "Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192)." ------------------------- FDA lashes out at Mylan for dismal quality control at HIV drug facility Facility making HIV drugs ignored bad quality control data, regulator says.An introduction to OOT (Out of Trend) results and an overview of the different types and how they are typically handled is also discussed using industry examples in the first session of this course.This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion.However, an improper correction in determining the results lowered the actual reported values.Without the improper correction, all lots would have been out of specification...." "Out of specification and reported out of trend results for impurities obtained in stability testing three lots of Doxorubicin Hydrochloride Injection, USP, were voided based on the investigations concluding that the approved sample preparation resulted in precipitation of the sample." "Folic Acid Injection was tested a total of five times for benzyl alcohol determination prior to acceptable results being obtained.Beth Mole - 4/11/2017, PM Mylan-the pharmaceutical company infamous for raising the price of Epi Pens-is in hot water with the Food and Drug Administration.This time, the dust-up is related to the quality control practices at one of the company's drug facilities making antiretroviral therapies (ARVs) used to treat HIV, Reuters reports.[2 I CFR 211.165(f) and 211.192].""Products with out of specification active ingredient assays are reworked. [21 CFR 211.15, 211.100 and 211.110].""There was no documented investigation as to why two.Sets of samples were placed on stability and why both sets of samples fell out of specification before the expiration date [21 CFR 211.166]." PDF file (156 KB) Cumberland Swan, Inc., 2002-02-11 "The inspection revealed a failure to validate cleaning procedures, routine release of and failure to investigate out-of-specification test results for a mouthwash product." PDF file (394 KB) Bachem California, Inc., 2002-01-14 "Your firm failed to conduct investigation(s) of out of specification results obtained during the cleaning validation for lyophilization trays." PDF file (383 KB) American Pharmaceutical Partners, Inc., 2001-12-10 "Investigation Report records that Doxorubicin Hydrochloride Injection, USP, lot 01990 14B, was out of specification and lots 190879 were out of trend.