Regarding this example
Assay limit: NLT 98.5%
Degradation Products limit: MNT 1.0%
If the API is in the “beginning” of its shelf life and the test results of it upon receiving it from API manufacturer are
98.8% and Degradation products = 0.90%
I think normally it will be accepted and will be used at that time in formulation with 2 years shelf life
Because it is within test limits
Uptil now I think that current practice holds
but its critical bcz in our set up people r not ready to waste the material they even use very low range of results too.
I think clear guidelines are needed regarding using safer narrower limits and regarding handling raw materials throughout their shelf life
Really this request reference number which will be sent to your email very soon is very important , to proceed for “further” questions (if any) regarding the same issue after EMA first reply to you regarding the issue
It is important also so that “further” replies from EMA regarding this issue reach you quickly
You are right we use the API having results near the limits many times. I think it is because the results of API have no value after formulation and formulated products must comply with its specification only.
This is why there is no guideline for it. API must comply only at the time when it is being used in the formulation.
I think the issue is solved now or anyone has any input.
my search conclusion is that its better not to use near expiry API.
If we use such API then we should have complete assurance n data regarding our product stability that it will comply specification for further 2 yrs.
Sr value of API will remain on top even after formulation of a product.
In finished product testing assay n dissolution testing depends on API value
You misunderstood my statement. I mean to say that the formulated product will be tested as per its specification and limits of API will not be considered anymore.
Moreover, the impurities and degradation products will be analyzed as per the formulated product specification. So the impurities and assay of the API will not have any relation to the finished product.
As per the above example, we’ll use an extra quantity of API to make its assay 100% in the finished product so its assay will not have any value in finished products.
Its degradation products will also be diluted in the finished product and this product will be analyzed for a new impurity specification. So it will not have any value in the finished product.
That is why we don’t need to care about the quality of API in the finished product, we have to care to comply the finished product with its specification.
It’s now clear. 
now its sounds good.
thanks sr.
simply we should have assurance of stability of our finish product.
Dear All,
I found a regulatory reference about corelation of usage of API and shelf life of drug product made out of that API.
The Indian Drugs and cosmetics Act 1940 and Rules thereunder 1945 (As amended up to the 31
st December, 2016) clearly states this requirement under Schedule M as follows,
Schdule M: GOOD MANUFACTURINGPRACTICES FOR PREMISES AND MATERIALS
1 GENERAL REQUIREMENTS:
10 Raw materials:-
10.9 Only raw materials which have been released by the Quality Control Department and which are within their shelf-life shall be used. It shall be ensured that shelf life of formulation product shall not exceed with that of active raw materials used.
However, the above reference is obtained from “Schedule M” in the Drugs and Cosmetics Act 1940 & Rules thereunder 1945 which is ammended up to Dec 2016 as I could not find the current status of this act and schedule even in the web site of CDSCO (India).
I request if anyone can check and confirm this aspect in the current version of Schedule M which is effective as on date. Please update me if there is any change in the above requirement.
This is effective as on date…
Ok, thanks. This means the same rule is still existing in the Schedule M of GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS
1 GENERAL REQUIREMENT: 10 Raw materials- correlation between raw materials’ shelf life and finished product in which it is used.
