In Stability testing if significant change occur then what
is the action plan?
Answers were Sorted based on User's Feedback
Answer / sitaramaraju kantasputhy
If it is at Development stage, then Formulation change or packaging change shall be done
If it at Exhibit batch study,then that should be addressed as OOT/OOS and same should be investigated.Then shall go for change in formulation or packaging
If it is at commercial batches then same should be addressed as OOS/OOT and should investigated.based on study product should recall.
Is This Answer Correct ? | 26 Yes | 1 No |
Answer / mihir
IF MAJOR CHANGES IS OCCURE THAT TIME CHANGE IN FORMULATION
IS DONE BEFORE THAT IF OUR PRODUCT FAILS IN ACCLERATED
STABILITY STUDY THEN WE ONCE GONE THROUGH WITH LONG TERM
STABILITY STUDY, AFTERWORG MAJOR CHANGES IS OCCURS THEN
REQUIRED CHANGES IN FORMULATION NECESSARY.
Is This Answer Correct ? | 5 Yes | 1 No |
Answer / fareena
if major change is occured during stability studies then
change in the formulation can be considered n change in
existing pkging material as well.
Is This Answer Correct ? | 3 Yes | 2 No |
Answer / dharmpal
change the formulation and keep temperature and humidity
Is This Answer Correct ? | 3 Yes | 11 No |
In resolution test of uv calibration ratio of 269nm & 266nm, respectively, using hexane as the reference . the acceptance criteria for the ratio is NLT 1.5 but always found that 1.3 ,why what i can do for the resolving the problem is it necessary to integrate exat at 269nm and 266nm ehat is limit of tollerence
What are the stability zones and stability conditions?
Why we use disodium tartare for determination of factor in karl ficher titration?
is there any entrance exam conducted for the post of drug inspector and what is the usual time
What is the formula for KF standardisation?
6 Answers Watson Pharmaceuticals,
Why we use pyrene in HPLC calibration ( UV-vis/PDA)
2 Answers Lupin, MSN, MSN Pharma,
How would you make a physician to prescribe your medicine rather than that of the competitor?
What will be in case stability sampleWhich have batch but distribute in three country.In tath case< we can put the sample for all country, whenevr all have same temp(Zone)
what type of column are used in GC
How do we choose HPLC or Gas chromatography for a sample analysis?
3 Answers Aurobindo, Hetero, PI Industries,
Which instrument used fbd fingerbag pore size identify purpose
how many types of deviations? describe