Reference can be found in USP<71>, as Tony points out.
Table 3. Minimum Number of Articles to be Tested in Relation to the Number of Articles in the Batch
Number of Items in the Batch* Minimum Number of Items to be Tested for Each
Medium (unless otherwise justified and authorized)**
Parenteral preparations
Not more than 100 containers 10% or 4 containers, whichever is the greater
More than 100 but not more than 500 containers 10 containers
More than 500 containers 2% or 20 containers, whichever is less
For large-volume parenterals 2% or 10 containers, whichever is less
Antibiotic solids
Pharmacy bulk packages (<5 g) 20 containers
Pharmacy bulk packages (5 g) 6 containers
Bulks and blends See Bulk solid products
Ophthalmic and other noninjectable preparations
Not more than 200 containers 5% or 2 containers, whichever is the greater
More than 200 containers 10 containers
If the product is presented in the form of single-dose containers,
apply the scheme shown above for preparations for parenteral use.
Catgut and other surgical sutures for veterinary use 2% or 5 packages, whichever is the greater,
up to a maximum total of 20 packages
Not more than 100 articles 10% or 4 articles, whichever is greater
More than 100, but not more than 500 articles 10 articles
More than 500 articles 2% or 20 articles, whichever is less
Bulk solid products
Up to 4 containers Each container
More than 4 containers, but not more than 50 containers 20% or 4 containers, whichever is greater
More than 50 containers 2% or 10 containers, whichever is greater
* If the batch size is unknown, use the maximum number of items prescribed.
** If the contents of one container are enough to inoculate the two media, this column gives the number of containers needed for both the media together.
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Tony Cundell
Sent: Wednesday, August 27, 2014 9:00 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Sample size needed for performing container closure analysis on stability for parenterals
MY understanding from the FDA guidance that you use 20 vials as in a sterility test
Tony Cundell
On Tue, Aug 26, 2014 at 8:11 PM, Chad Genson <[log in to unmask]> wrote:
> I believe this question has been asked before, but I would still like
> to clarify a few things. I am trying to determine how many vials to
> analyze on stability through blue dye ingress analysis on a lot of
> material which has a 9,000 vial lot size. What is a statistically
> sound number of vials to analyze when the product is still in clinical
> trials and the material is quite costly? Can you perform CCI testing
> on as little as three vials, one from each the beginning, middle, and
> end of the lot when testing is scheduled? Is there a specific
> confidence interval which must be met for this type of testing, and is
> it expected that the number of vials tested is adjusted for each lot
> size of vials manufactured? Any help will be greatly appreciated.
>
> Thanks,
>
> Chad
>
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The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.
------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community. Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Hardy Diagnostics - http://www.HardyDiagnostics.com
Provides a complete selection of laboratory and microbiology supplies
for the clinical, industrial, and molecular biology research communities.
=================================
The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.
------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community. Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Hardy Diagnostics - http://www.HardyDiagnostics.com
Provides a complete selection of laboratory and microbiology supplies
for the clinical, industrial, and molecular biology research communities.
|
