difference between temporary change control and deviation
Answer Posted / manusb07
Temporary change control and deviation
Change control: It is a documented procedure wherein we can make changes in an approved procedure, process, equipment, method for better improvement without impacting the product quality and before implementing such changes, approval of Quality unit must be needed.All the changes made through change control procedures are PERMANENT, they are not TEMPORARY.
Deviation: There are two types of deviations
Unplanned: It is the situation where we did not follow the written procedure which is against cGMP. in such cases a deviation is need to be filed and investigation must be done and accordingly CAPA must be taken.
Planned: It is the situation where we can not follow the written procedure due to technical problem and we must deviate the procedure to process further. such planned deviation must be minor in nature and are for TEMPORARY only. Before making any planned deviation, Impact assessment shall be done. If we want to make such changes permanent then change control procedure must be used.
or we cannot follow (planned) the approved procedure to p
Is This Answer Correct ? | 3 Yes | 1 No |
Post New Answer View All Answers
What is difference between assay and content uniformity ?
plzzz..send me the pevious papers of drug inspector for uppsc....i.l b highly oblige
A patient reports not experiencing the desired relief from their anxiety symptoms after a few weeks of Alprazolam treatment. How would you assess and adjust their treatment plan?
What skills would you look for while hiring a pharmaceutical representative?
why dissolution multimedia profile of drug is important. what are the specifications for tablets ,capsules,powders etc
Why we use potassium hydrogen pthalate for determination of calibration in Total organic carbon
How to check the integrity of Sieve, Screen, FBD Bag?
Can you explain the pharmacological mechanism of Alprazolam and how it interacts with the central nervous system?
In dissolution test why sample is withdrawn from top of the paddle and not less than 1 cm away from wall?
HI, I srinivas , was shortlisted for interview of Ph.D. PROGRAMMES FOR ACADEMIC SESSION 2012, I have interview on 17-nov-2011. Sir can you tell me about interview, how to prepare for it. How it will be? It's my first interview sir, i don't know how to face it. Kindly help me sir, Thanking yoU,
what are all the parameters to be considered while applying bracketing and matrixing?where and all it is applicable?
Why we said Glacial Acetic Acid to Acetic Acid m
Why do you want to make a career in pharmaceutical?
What do you mean by Bracketing and Matrixing in stability?
Why and When RRF is necessary in RS method? How it is helpful in method development?