what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control
Answer Posted / gopala krishna gnanga
Deviation means when we have any written procedure like SOP,STP,BPR,protocol etc, and someone works against this,then it is called Deviation.It means Deviation from any written procedure that we have implemented.
Change Control means a document that control any change (new or up gradation) in your current quality and change control. If there is deviation happen and as CAPA of it one needs to upgrade the system then you need to file change control
| Is This Answer Correct ? | 2 Yes | 1 No |
Post New Answer View All Answers
how to calculate potency of working standard by using mass balence method & this calculated potency is on as basis or on anhydrous/ dried basis
What r the different sop in or plant
difference between RF and correction factor?
What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan
how many clauses are there in iso? give me the clauses details?
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.
Tell us about your oncology experience.
Caffeine standard is recommended by the monograph for HPLC wavelength accuracy calibration. It is covered range of 205 to 273 only.If the method have wavelength beyond the range, then how it supports for instrument performance?
How to preform dissolution profiling
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...
from hplc chromatogram how can we say that calibration is needed now?
What is difference between Warm and Lukewarm Water as per pharmacopia.
what is your experience in medical continuing education.
Tell us about a time when you failed to meet a deadline. What were the repercussions?
How to perform forced degradation on tablet sample or suspensions?