Setting Solid Dose Drug Fill Count Ranges

M

Manicjewels1

#1
Good Morning Everyone,

I am trying to find some guidance on how I should set up solid dosage fill count ranges. I do know that the FDA does not cover this part and is more generalized. Can anyone send me to any links or give me guidelines on how I should go about defining a process for solid dosage fill counts in bottles. ASTM has ranges for critical, but does not specify major or minor range criteria. Any help would be appreciated. I know that whatever ranges I decide on should be based on a statistically sound decision with how I came to the decision for the final ranges.

Thank You,

Desperate :deadhorse:
 
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#2
I merged your two threads since they are identical. This is out of my area of expertise, but hopefully someone will be able to help you.

Do remember that it often takes a day or two for an answer since the people who help by answering questions are donating their time to do so. And sometimes there's no one here that knows the answer. If no one replies today or in a day or two one of us will probably "Bump" the thread to try to get a reply.
 
M

Manicjewels1

#3
Do you think you could bump this post? I might have it in the wrong forum.

Thanks,

Julie
 

v9991

Trusted Information Resource
#4
It would be helpful to respond if you can indicate specific dosage form or pack at-least you are talking about;

here''s few points based on my experience... the compliance of product to local regulations(pharmacopoeia) is mandatory...
; so generally, pharma follows USP (united states pharmacopoeia) or European Pharmacopoeia and any other local pharmacopoeia.
there are expectations set for various category of products...
1) powder filled sachets...
2) powder for injections...
3) lyophilized powder for injections...
4) fill-count of tablets in the bottle pack....!!!

here's 1 quick reference...on weight variation...
and <905> UNIFORMITY OF DOSAGE UNITS
http :// www. usp. org/sites/default/files/usp_pdf/EN/USPNF/2011-02-25905UNIFORMITYOFDOSAGEUNITS.pdf - DEAD 404 LINK UNLINKED

check out sec.5.2.....WHO Pharmacopoeia Library

this one more talks about process development & confirmation...(not batch release)
http :// www .fda. gov/ohrms/dockets/dailys/04/jan04/013004/03D-0493_emc-000003-01.pdf - DEAD 404 LINK UNLINKED

hope this helps...
 
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v9991

Trusted Information Resource
#7
if I understand your query...you are talking about fill count of products in the product-packaging.

if its unit packing...its obvious...acceptance criteria is ''Nil defects''; (note that severity could be low, cause it is easily detectable, patient could notice it upfront)

if its bulk packing...such as bottle pack...its not very obvious(note that severity could depend upon the dosage regimen...+ its detectability by end user is relatively low, untill unless the variation is really significant it may not be really noticeable.)...here the acceptance criteria would depend on the variation-acceptable from dosage regimen...or patient instructions...

above all, regulatory wise,,,yu ought atleast comply with pharmacopoeia requirements.
hope this helps...
 
M

Manicjewels1

#8
Yes I am talking about bottle fill counts for tablets or capsules only for packaging not manufacturing. Such as a range set for 95 to 100 count, with a label claim for 100ct bottles etc..... I first need to define a set count range for the tablets or capsules with a statistically sound explanation of how I chose the range , than depending on the the level of variance, determine how to define them as critical, major or minor depending on where the tablet or capsule count falls between the range, or above or below the range.

Sorry for not explaning properly.
 

v9991

Trusted Information Resource
#9
as mentioned briefly earlier, the range to be arrived based on the
need of product category,
customer/patient impact,
regulatory requirements...etc.,

all the references are towards the 100% accuracy.... (bound by the above criteria) you will find many other references but here's little more.
http://www.ppma.co.uk/pubs/pdf/MU-2002-September-counting.pdf

however, have a look at the certain other references...
Typical Suitability Considerations for Common Classes of Drug Products
http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070551.pdf
 
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