what is the cleaning validation?

Answer Posted / kanakadurga

Cleaning validation for is the methodology used to assure
that a cleaning process removes residues of the active
pharmaceutical ingredients of the product manufactured in a
piece of equipment, the cleaning aids utilized in the
cleaning process and the microbialattributes. All residues
are removed to predetermined levels to ensure the quality of
the next product manufactured is not compromised by waste
from the previous product

Is This Answer Correct ?    11 Yes 0 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

Describe your field experience sample type collected,sample techniques,field measurements taken and equipment used?

2364


when we talk about change in entropy we consider total entropy means of surround +entropy of system but when we talk about change in Gibss free energy we consider entropy of system.explain with reason.

1632


Why we select scan range from higer wavelength to lower wavelength in uv visible spectroscopy and ftir spectroscopy ? .

546


If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately

446


before starting analytical method valodation what you checking? and how giving preference to start validation?

454






what is the extinction coefficient for Indomethacin or at 319nm wave length.

3611


what is the principle involved in turbidometry and nephelometry ?

3733


what is the purge flow & how to calculate

2094


How would you decide dissolution medium for NCE compound of class I drug

1810


how we can identify the impurity is coming below loq at transfering site?

481


In which situation we require to analytical method validation of excipient?

407


[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?

386


Why are use silicon oil mr?

849


can i use hplc detector to uplc and why?

1892


I have compare C2H2-air and C2H2-N2O flame AAS on determination calcium. Both use same range of std to plot calibration curve. (2-6ppm) When i measure the sample with phosphate, KCl and LaCl, C2H2-N2O flame give false positive result, around 0.5ppm. When i measure the sample with phosphste, KCl and EDTA. C2H2-N2O flame also give 0.5ppm false positive. But both above mentioned sample would not give false positive when measured by C2H2-air flame. What is the reason?

3096