Difference between Change control and Deviation please give the answer elaborately
- 1 Answers
- 2235 Views
- Rakshit Drugs, Smilax, I also Faced
- E-Mail Answers
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.
| Is This Answer Correct ? | 0 Yes | 0 No |
why increase any other impurity in citicoline table
which type of data need to file ANDA submission in USA ?
Give an example of how you've handled a problem patient.
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?
what are the limits for LOD and LOQ? should it be necessarily less than 1?
what is a difference between drug purity and drug potency?
are vaccines for long term or short term?
2 Answers GSK GlaxoSmithKline,
What is forced degradation study?
How are you qualified for the position of Assistant Clinical Director?
What is difference between Warm and Lukewarm Water as per pharmacopia.
difference between related substances and purity?
1 Answers Micro Labs, Zydus Cadila,
from hplc chromatogram how can we say that calibration is needed now?
0 Answers Lupin, Teva Pharmaceuticals,
Pharmacy 
