What is the difference between Deviation and Out of
Specification ?

Answer Posted / 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



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

You will be required to interact with patients. Tell us about your previous experience with patients and how did you deal with the experience.

1701


What experience do you have in training?

1944


What are your intentions towards the uplift of the hospital.

1667


how many clauses are there in iso? give me the clauses details?

2162


If calibration of 12 bowl dissolution apparatus does not meets single stage procedure, how can u proceed calibration?

2957






while formulation of Gliclazide floating tablets why we are using direct cmpression technique why not wet granulation and what happend with that

2081


concomitant administration of 6-mercaptopurine and which product results in severe bonemarrow suppression?

2195


What is difference between Warm and Lukewarm Water as per pharmacopia.

1056


what is factor?

1754


What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan

1933


Tell us about your oncology experience.

2051


Tell us about a situation in which you took the extra step for a patient.

2806


What do you mean by GTT? What are the effect of GTT on film coating.

1203


What aspect of your communications skills have you improved the most in and how did you accomplish this improvement?

1866


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.

2248