what is the diffirence between deviation and change control?
at what situations we can raise the deviation and change
control

Answer Posted / nilesh l patel

change control is a adition process of current and new process or method or equipments ,like: 1>new sop preparation 2> upgrade previous sop or method or process for better gmp complience.it may be tempery or permenant,and depends on requirement of perticular department through QA and intimation should be sent to all concern deparments for this change.

deviation is a process of changing product specificaton ,process,method through change control with permission of concern dept hod and QA AUTHORITY FOR THAT THEY GO THROUGH INVESTIGATON RESULTS, AND CAPA PROCEDURE.

Is This Answer Correct ?    18 Yes 19 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

pls send me last two years solved papers of health & malaria inspector to kumar.santosh087@yahoo.com

1560


Why SLS used as dissolution medium

664


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

2195


What skills have you acquired that would apply to the position of Clinical Data Manager?

2058


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

2162






What r the different sop in or plant

1524


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 is factor?

1754


Tell us about your oncology experience.

2050


What are your intentions towards the uplift of the hospital.

1667


when we connect the capacitor banks in series with the circuit? 2 144 pH is having unit?

1787


What was your most difficult experience with this population and how did you deal with it?

1656


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

2957


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

1056


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?

1205