Dear forum members,
I would like to know the clarification for the below given situation
"An API is approved and packed (50kg per drum) as per customer requirement and preserved for a period of one month. Assume the material was not dispatched due to some reason and the same was repacked (25kg per drum) and supplied to another customer as per their requirement. The material does not contain any microbial specifications and it is sure that it will pass with respect to all specifications. Hence the repacked material was not analyzed and released".
Now i would like to know the clarification for the above said practice which is violating the GMP rules or not and if so which clause is guiding to re analyze the re-packed material.
Your valuable inputs are very much appreciated.
[b]There are few issues here.
When you have sent that material you have COA & COQ. What was the date of analysis?
Do you have a standrad pack size? Did it deviate from that pack size–if so what are risks involved?
Who released this product for packing with out reanalysis?
How does the head space in both packs effect the quality of material?
Was repacking a standard practice or its done on special requirement? If so what deviation you will write from your BMR and release slips?
FDA looks seriously into these matters.[/b]Well I know its India and Bulk drugs units do not care a damn unless otherwise it is an export product to US or EU.
You can refer the Drug & Cosmetic Act 1945 clause 74-A is require the testing while re-packing.
Similarlly FDA had also published the CPG Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPs " In CPG certain exception are given…if your case fall under this category_just check it out".
Happy Reading !
I agree with Mr. Durga Prasad that the risk involved in the stated conditions. And as per Mr. Ashish the FDA published guideline on repacking of Drug products. but in the above case it is Drug substance, hence i request the clarification.