Hello,
Can any body share with us the SOP for Maintaining the Inventory &
Inspection for Stability samples.
Regards,
Makarand Mulherkar
On 30 November 2011 19:41, Phillips III, John
<[log in to unmask]>wrote:
> Hello,
>
> I believe this CFR refers to retains / reserve samples from manufacturing
> and does not set forth a requirement to perform yearly inspections of
> stability samples stored in stability chambers.
>
> John Phillips
> Pfizer, Inc.
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:
> [log in to unmask]] On Behalf Of [log in to unmask]
> Sent: Tuesday, November 29, 2011 4:26 PM
> To: [log in to unmask]
> Subject: Re: [PSDGLIST] Annual stability inventory & inspection
>
> See text below. Reference 21 CFR 211.170
>
> (b) An appropriately identified reserve sample that is representative of
> each lot or batch of drug product shall be retained and stored under
> conditions consistent with product labeling. The reserve sample shall be
> stored in the same immediate container-closure system in which the drug
> product is marketed or in one that has essentially the same
> characteristics. The reserve sample consists of at least twice the quantity
> necessary to perform all the required tests, except those for sterility and
> pyrogens. Except for those for drug products described in paragraph (b)(2)
> of this section, reserve samples from representative sample lots or batches
> selected by acceptable statistical procedures shall be examined visually at
> least once a year for evidence of deterioration unless visual examination
> would affect the integrity of the reserve sample. Any evidence of reserve
> sample deterioration shall be investigated in accordance with §211.192. The
> results of the examination shall be recorded and maintained with other
> stability data on the drug product. Reserve samples of compressed medical
> gases need not be retained. The retention time is as follows:
>
>
> Barb Portinga
> CSL Behring LLC
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:
> [log in to unmask]] On Behalf Of Wong, Amy
> Sent: Monday, November 28, 2011 12:20 PM
> To: [log in to unmask]
> Subject: [PSDGLIST] Annual stability inventory & inspection
>
> Hi Stabilitarians,
>
> Does anyone know the specific reference requiring annual inventory and
> inspection of stability samples?
>
> Thanks,
> Amy
>
> =================================
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> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. -
> http://www.StabilityEnvironments.com<http://www.stabilityenvironments.com/>
> High quality controlled environmental walk-in rooms and reach-in chambers
> Full installation, validation and spare parts also available
>
> Environmental Specialties - http://www.eschambers.com/
> Manufacturer of Quality Stability Chambers and
> Provider of Complete Validation & Calibration Services
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> CSL Behring
>
> =================================
> 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.
>
> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. -
> http://www.StabilityEnvironments.com<http://www.stabilityenvironments.com/>
> High quality controlled environmental walk-in rooms and reach-in chambers
> Full installation, validation and spare parts also available
>
> Environmental Specialties - http://www.eschambers.com/
> Manufacturer of Quality Stability Chambers and
> Provider of Complete Validation & Calibration Services
>
> =================================
> 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.
>
> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. -
> http://www.StabilityEnvironments.com<http://www.stabilityenvironments.com/>
> High quality controlled environmental walk-in rooms and reach-in chambers
> Full installation, validation and spare parts also available
>
> Environmental Specialties - http://www.eschambers.com/
> Manufacturer of Quality Stability Chambers and
> Provider of Complete Validation & Calibration Services
>
--
Makarand Mulherkar
Group Technical Director
MAKJAI GROUP OF COMPANIES
KOLHAPUR
00-91-9325699001/9822379001/9325695917
Website: www.makjaigroup.com
=================================
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.
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
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
|
