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September 2012

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Subject:
From:
Brian Matthews <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 14 Sep 2012 18:54:20 +0100
Content-Type:
text/plain
Parts/Attachments:
text/plain (150 lines)
When you simulate use of the product it is possible for it to be
contaminated.  Therefore monitoring for such contamination would be
sensible.

In addition, an in-use PET should be undertaken.

Chemical stability of the AI and essential excipients should also be
monitored.

Bear in mind that the Ph Eur requires a use period of (not more than) four
weeks unless otherwise justified and authorised.  Thus the in-use stability
study should reflect this (and the recommended dosage instructions).

Regards,

Brian Matthews.

On 14 September 2012 09:18, Ramchandra Tallu <[log in to unmask]>wrote:

> Dear Forum Members,
>
>
>
> We are designing in-use stability study protocol for one of our Eye Drop
> formulation product.
>
>
>
> In this regard I am referring EMEA guide “NOTE FOR GUIDANCE ON IN-USE
> STABILITY TESTING OF HUMAN MEDICINAL PRODUCTS” dated 1 March 2001.
>
> As per this guide, appropriate physical, chemical and microbial properties
> of the product susceptible to change during use should be monitored.
>
>
>
> My question is which test parameters are studied during in-use stability
> testing for microbial properties and at what interval?  The product is
> sterile and to be used within 28days after opening.
>
>
>
> Share your valuable comments.
>
>
>
>
>
> Regards,
>
> Ramchandra
>
>
>
>
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