What is the difference between Deviation and Out of
Specification ?
Answers were Sorted based on User's Feedback
Answer / prasad
Deviation is departure from approved instruction/procedure.
Eg: The activity not following as written in procedure.
OOS: The analytical result is not meeting the predefined
specification.
Is This Answer Correct ? | 41 Yes | 6 No |
Answer / pramod k g
Deviation:- pre defined procedure not followed accuretly as
transcribed in a proedure
OOs: results Obtained with defined procedure not meeting
the acceptance limits
Is This Answer Correct ? | 26 Yes | 1 No |
Answer / alexander
Deviation : That means the Deaviating from Standard may be due Analyst or machine Failure
But OOS : Out of Specification means to Not Found satisfactory with a prescribed Limit
My be Valid Or Invalid Depending upon Analyst performace
Is This Answer Correct ? | 7 Yes | 1 No |
what is factor?
using of chemical standards in HPLC he customer gave 100.2% what potency i will use this potency in hplc?
what is meant by CAPA?what is the source for deviation (unplanned) to occur, though the process developed by standard validation procedures?
3 Answers GSK GlaxoSmithKline,
Assume that you've been hired for the position. A mother calls and says her child is sick and she needs an appointment this morning. You don't have an open appointment for the morning. What will you do?
Iam a B.PHARMA GRADUATE from DELHI UNIVERSITY and I am looking forward for DRUG INSPECTOR EXAM..kindly mail me any ques papaers reg the same...
what is ur strengths and weekness in ur professional life as medical rep?
How to set impurity limits for Related substances test.
why nitrogen charecter as a inert gas plz identified
what do you call "talking while sleeping at night" in english langusge?
Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
0 Answers Alchem, Getz Pharma Research, Hovid Berhad,
How to perform forced degradation on tablet sample or suspensions?
What aspect of your communications skills have you improved the most in and how did you accomplish this improvement?