Hi there, I would like to know what the time line is for when bulk product is to be tested for release to be packed or how long after bulk product is manufactured should the bulk be tested to be released for packing?
I hope my question is stated clearly.
You have to establish the holdtime data for the bulk product and you can hold under controlled conditions as long as your hold time sample analysis for the product complies with the product specifiations.
However commoly followed practice for oral solid formulations is as follows
Blend : 30 days
Coated tablets : 90 days
Uncoated tablets : 30 days
[quote=srikanth04gene]You have to establish the holdtime data for the bulk product and you can hold under controlled conditions as long as your hold time sample analysis for the product complies with the product specifiations.
[b]However commoly followed practice for oral solid formulations is as follows
Blend : 30 days
Coated tablets : 90 days
Uncoated tablets : 30 days[/quote][/b]
Thanks for your reply.
I understand that one must have holding time data for bulk to be kept for period X before packing but what I’m asking is what is the time limit for testing the bulk after it being manufactured.
What I bolded where is that stated, what guideline?
The time limit of testing is not a standard or thumb rule for all products. After the preformulation studies and once it is transferred into pilot scale such studies will be performed. I think guidelines are available for such studies. I will soon find and attach the same here. Formulation and Development department will carry out such studies initially.Many products will have to be stored under prescribed conditions of mositure control & temeperature control. Hygroscopic products, Temerature sensitive products and some products in which Bacteria or Bacterial spores are added will have different hold times.For example: The H1 antagonist Omeprazole is higly hygroscopic. Its blend stability is limited and it should be compressed at around 20-22C at relative humidity not more than 45.So not all products will have same guidances. There are certain producst which are attracted by OEL guidelines they do have different product blend hold times. These guidelines of Formulations are ever changing.
A part of Guideline enclosed.
During the pilot scale we used to put 2 batches for Bulk hold time study and test for risk based product degradation studies.
No two oral dosage form is similar
The differences exists in
-API
-Excipients
-Dry or wet blending
-Granulation
-Compression parameters & Hardness
-Colourants
-Coating solutions & Coating times
-Thermal stability and Hygroscopicity of the Product along with Excipients
-Some reactions do happen when they get Dried(Due heat) like Browning–Preventing such things not to happen and care taking
-Packing charecterestics-- Blister/Strip/Alu Alu/ Bulk Bottle/Bulk plastic container
-The holding of Processed bulk in a SS container or a Plastic container 9Holding conditions and Time) etc etc…
Guideline.pdf (58.0 KB)
Thank you DURGA PRASAD for your replies.
Once again I’m miss understood regarding my question. It seems there is no time limit for testing bulk product after manufacturing.
Please understand my question, I’m not asking for bulk holding time guidelines or references to that. All I was asking was “what is the time limit for testing bulk product after the bulk product was manufactured”. I understand that hold time data is required to keep bulk for longer periods prior to being packed.
Note:
My question is about the time limit for testing after the product is manufactured (point 1) and when it is required to be tested (point 2) or point 4 when the packed product is tested instead of the bulk.
I hope this will make my question clear and it’s not about holding time but when testing must be done.
My question is about the time limit for testing after the product is manufactured (point 1) : There is no standard time limit. Normally maxiumum 30 days is taken. But it all depends up on Compound, Excipient, Formulation, Stability, Interaction of API-Excipient, Interaction with storage and humidity conditions
when it is required to be tested (point 2) : Normally we tested 2 batches. We tested every day. We ensured that these conditions are properly maintained and documented during storage.
4 when the packed product is tested instead of the bulk : This is done during the stability studies. I would say the routine stability data collected. You need to follow ICH stability for packed product stability.
Thanks Durga Prasad,
I appreciate your patients and the time you put in in answering ones questions.
So there is no real standard on when bulk should be tested after manufacturing - thanks for your answer on this one. I was so hoping that there is at least some kind of guidance in some pharmacopea on this.