Following are the guidelines for stability study conduction for new products:
1. Formal stability study should consist of accelerated and long term stability testing on at least two primary production batches for stable drug products and in case of the susceptible drug products at least three primary production batches should be considered.
2. The accelerated stability testing data at 40°C / 75% for minimum six months and long term stability testing data at 30°C / 65% for minimum 12 months should be available at the time of submission for new drug application and can be continued further.
3. The product stable for 6 months at 40°C / 75% (Accelerated stability testing conditions) then it can be assigned the shelf life of 24 months.
4. If the shelf life period exceeding the 24 months is to be assigned to the product the real time stability testing data should be available.
6. The shelf life of 36 months or more can be assigned to the drug formulation after completion of long term stability testing for 36 months or more.
7. If there is a change in the primary packing material the product should be treated as the new product for conduction of stability studies.
8. The stability studies should be performed on each individual strength of the drug product unless bracketing is applied.
9. If the same product is having the different doses (different strengths) and identical production formulation, and but different production process then each should be treated as a new product the stability study should be carried out separately for each of the strengths.
10. The frequency of the testing for long term stability testing should be initiated and after every 3 months over the first year, every 6 months over the second year and annually thereafter throughout the proposed shelf life.
11. The frequency of the testing for accelerated stability testing should be initial 3 months and 6 months.
12. While labeling the stability samples the terms ambient conditions or room temperature are not acceptable.
14. Out of three batches selected for stability study testing, the at least two batches should be pilot scale batches and the third one can be smaller if justified.
15. The photostability testing should be carried out on at least one primary batch of the drug product.
Also see: List of Current ICH Quality Guidelines for Stability
2. The accelerated stability testing data at 40°C / 75% for minimum six months and long term stability testing data at 30°C / 65% for minimum 12 months should be available at the time of submission for new drug application and can be continued further.
3. The product stable for 6 months at 40°C / 75% (Accelerated stability testing conditions) then it can be assigned the shelf life of 24 months.
4. If the shelf life period exceeding the 24 months is to be assigned to the product the real time stability testing data should be available.
6. The shelf life of 36 months or more can be assigned to the drug formulation after completion of long term stability testing for 36 months or more.
7. If there is a change in the primary packing material the product should be treated as the new product for conduction of stability studies.
8. The stability studies should be performed on each individual strength of the drug product unless bracketing is applied.
9. If the same product is having the different doses (different strengths) and identical production formulation, and but different production process then each should be treated as a new product the stability study should be carried out separately for each of the strengths.
10. The frequency of the testing for long term stability testing should be initiated and after every 3 months over the first year, every 6 months over the second year and annually thereafter throughout the proposed shelf life.
11. The frequency of the testing for accelerated stability testing should be initial 3 months and 6 months.
12. While labeling the stability samples the terms ambient conditions or room temperature are not acceptable.
14. Out of three batches selected for stability study testing, the at least two batches should be pilot scale batches and the third one can be smaller if justified.
15. The photostability testing should be carried out on at least one primary batch of the drug product.
Also see: List of Current ICH Quality Guidelines for Stability
pharmaguidleines.com.... simply great work.......
ReplyDeleteWhat is the testing frequency of samples in Accelerated stability studies as per WHO guidelines. (0,3,6 or 0,1,2,3,6) TRS-953 says a minimum of 3 points 0,3,6 is justified. Is there any guidelines which ask for 0,1,2,3,6 months
ReplyDeleteAt the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended.Follow to ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products
Deleteis there any new guidelines for long term stability
ReplyDeleteI got the new msg of 30/65 changes to 30/70 ?
Which is your stability zone?
DeleteNo any change supposed change the condition then we have study to update ich guideline
Deletewhat is reference for all above if we are manufactured generic drugs
ReplyDeleteSir can u tell me about new guideline of stability
ReplyDeleteSir kindly guide if pharmaceutical item having storage temperature 2-8•c can be stored for one hour in 25 degree...
ReplyDeleteIdeally no but check manufacturer guidelines for the same because it depends upon material.
DeleteFor a global company, if you have a stable product under Zone IV condition, is this accepted by all authorities for other zones like Zone I and II. Thus, are Zone IV stabity study also accepted for I and II and studies with lower temp and humity are not required for submission in Zone II? Thanks for anwer.
ReplyDeleteWhat conditions are considered as an accelerated stability condition?
ReplyDelete