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

analytical method validation require to with respect to release specification or shelf life specification?

278


how can give the expiry period and restadardisation of volumetric solution

2047


Which parameter require to do for analytical method equivalency?

320


Home heating oil or furnace oil what is made from? Can (base oil plus diesel/kerosen) = home heating oil?

1690


what is difference in ods I ods II is this is realy from sorbent / packing characteristics or from other means

1485






What is column in chromatography?

1759


How we performed the force degradation for drug substance, is any specific guideline is available for each parameter(Acidic, basic, oxidation,heat)? what conditions you mentained for above parameters.

1788


While performing TOC sst analysis Zero shift disabled & sample analysis zero shift enabled why?

2348


What is third generation HPLC Columns?

1507


What is control room temperature and which guide line says?

1154


Related substance method equivalency on control sample or spiked sample?

299


what is mean by 40 in the dissolution basket mesh size?

287


what is mean by ambient temperature?

340


WHAT IS THE PARAMETER FOR THE SELECTION OF MOBILE PHASE IN HPLC?

641


what is diffrence between specificity and selecivity?

306