Interested to Buy Any Domain ? << Click Here >> for more details...
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)
- 5 Answers
- 9763 Views
- Cipla, Wipro, I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / shoukatalli
Stability of sample doesnot depend on material you had sent
in different coutries.you should carry long term stablility
of only one retained sample as per ICH guidelines (temp and
humidity conditions).
| Is This Answer Correct ? | 9 Yes | 1 No |
Answer / kishor solanke
Stability testing does not depend upon their standard of
release e.g. EP, USP, JP or what ever it may be OR where u
had sent these batches If their MKT are same & no change in
their requirement conditions then only same samples can
represents the stability for all countries.No need to
charge saperately.
| Is This Answer Correct ? | 2 Yes | 0 No |
Answer / ali mostafa
You should check the mean temperature/Humidity of the
country the product will be sent, and according to that
adjust the stability program.
If the three countries have the same climate zones,and we
have a good stability results for that zone (from ICH
guidelines),we can put the sample for all three countries.
| Is This Answer Correct ? | 3 Yes | 2 No |
Answer / parag
Depending upon the mean kinetic temperature we have to put
and analyse the sample for the three countries seperetly
| Is This Answer Correct ? | 1 Yes | 1 No |
Answer / sumit tyagi
If all three country having same climate zone or same container closer is used for all three country then only single sample study represent the result for all three country.No required charged Sample separately.
| Is This Answer Correct ? | 0 Yes | 0 No |
What is the difference between Calibration & Validation?
why we study matrixing in stability system in stability study and on what basis we select time point.
Give details of pilot plant?
what is the exact classification of pharmaceutical industry (area wise) as per cleaning limits(Class A.B.C.D)
why we use matrixing method in stability study and on what basis time points are selected?
if calibration of 12 bowl of dissolution apparatus does not meet a single stage how you can proceed calibration
what is recovery factor
why dissolution multimedia profile of drug is important. what are the specifications for tablets ,capsules,powders etc
what is mean by stability study?
What is the importance of negative pressure in coating pan during coating ?
Why do you want to make a career in pharmaceutical?
how we can fix re-standardization due date in volumetric solution
Pharmacy 
