June 2012


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Raphy Bar <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Tue, 5 Jun 2012 20:13:37 +0300
text/plain (172 lines)


As I am teaching a course on Stability Storage Programs, I was able to
locate guides that explicitly address the stability testing at several


ICH Q5C (See below!) is explicit.  A WHO guide (See below!) on Vaccines also
requires two positions. The Asean Guideline on Stability Study of Drug
Product addresses several times this point for several types of drug


I hope this helps!





Raphael (Raphy) Bar, PhD

BR Consulting









6.5. Container/Closure

Changes in the quality of the product may occur due to the interactions
between the formulated biotechnological/biological product and
container/closure. Where the lack of interactions cannot be excluded in
liquid products (other than sealed ampoules), stability studies should
include samples maintained in the inverted or horizontal position (i.e., in
contact with the closure), as well as in the upright position, to determine
the effects of the closure on product quality.





OF VACCINES, WHO/BS/06.2049 - Final


5.4.2. Vaccine presentation, container and closure system

In addition to the data on stability of the final formulation, other factors
that may affect

vaccine stability during its use should also be tested in the stability
study. Potential interactions

between the vaccine and container and closure system are particularly
important for vaccines in

liquid form. The impact of the closure system on vaccine stability and
quality in general should

be tested by exposing and maintaining samples into different positions
during a certain period of

time. These positions should mimic possible situations that may occur during
the transport and

storage and that provide contact between vaccine and the closure system
(upright; horizontal or

inverted position).






> -----Original Message-----

> From: Pharmaceutical Stability Discussion Group 

>  <mailto:[mailto:[log in to unmask]]>
[mailto:[log in to unmask]] On Behalf Of Christine Smithson

> Sent: Tuesday, May 15, 2012 8:50 AM

> To:  <mailto:[log in to unmask]> [log in to unmask]

> Subject: [PSDGLIST] Guidelines for inverted / upright storage of glass 

> vials


> Dear All

> Does anyone know of a guideline that states that vials should be inverted
when stored for stability studies?

> Many thanks

> Christine


> Christine Smithson

> Stability Study Manager

> Group Product Upgrade


> Pharmacare Limited trading as Aspen Pharmacare P O Box 4002 Korsten 

> Port Elizabeth

> 6014

> Switchboard Tel No: +27 (0) 41 407 2111 Tel No: +27 (0) 41 407 2122

> Fax: +27 (0) 41 407 2021

> Cell: +27 (0) 82 464 6330



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