Sterility Testing - USP Chapter 71 and ISO 11737-2

Nash27

Involved In Discussions
We have been issued with non-conformance from our regulatory authority for the sterility test (gamma sterilisation using VDmax25 method) were not performed with reference to the ISO 11137-2: 2012 standard where it require the use of ISO 11737-2-2009 Sterilisation of medical devices - Microbiological methods - Part 2- Tests of sterility performed in the definition, validation and maintenance of sterilisation process

As manufacturer we have referred to the USP Chapter 71 sterility test method to perform the sterility test and referred it in the Gamma validation report as well as in subsequent dose audit report.

I have compared the ISO 11737-2 standard vs USP Chapter 71 Sterility test and for my personal opinion USP 71 provides detailed method on how to perform sterility test where as ISO 11737-2 is guideline document at only one section it describes how to perform sterility test.

To address this non-conformance I have planned to perform kind of gap analysis / similarities between ISO 11737-2 vs USP Chapter 71 sterility test as well inclusion of reference of ISO 11737-2 in the dose audit report. This way I can demonstrate the sterility test performed using USP chapter 71 holds same authentication as that of the ISO 11737-2 guideline. Also, parts of the standard refers to the pharmacopoeial monographs. I guess I failed not to making reference to ISO 11737-2

(We use external service provider to conduct the sterility test and as per their procedure guideline they refer to the USP chapter 71 and also report the same in the sterility test result report, the lab do not refer to ISO 11737-2 standard).

Please someone let me know on my approach, is this a right way?
 
M

MIREGMGR

Re: Sterility Testing:- USP Chapter 71 and ISO 11737-2

From your description, it appears there's a discrepancy between what your regulatory authority wants and what your contract sterilization lab does.

Is your contract sterilization lab subject to the same regulatory authority, and if so, in conformance with the applicable regulations?

Do you have a certificate from an independent certification body pertaining to your sterile production processes and validations, such as (if you export to the EU) a CE certificate?

If so, does the certification body that issued that certificate have a microbiologist audit your and your service provider's sterilization related processes and validations?
 

Nash27

Involved In Discussions
Re: Sterility Testing:- USP Chapter 71 and ISO 11737-2

Thanks MIREGMGR,

1. Our contract laboratory not reviewed by the TGA. It operates under ISO 10725 and approved by us.

2. Our contract manufacturing facility is ISO 13485: 2003 certified by notified body. Our company has conformity assessment certificate issued by the TGA for the sterile product that we manufacture and distribute in Australia.

3. No microbiologist audited the laboratory either from notified body or through the TGA

I am getting serious after your questions, wouldn't be my approach of comparing USP 71 vs ISO 11737-2 valid to address the non-conformance, the TGA auditor kind of agreed on my approach at the closing meeting. Please let me know your feedback.

Thanks
 
M

MIREGMGR

Re: Sterility Testing:- USP Chapter 71 and ISO 11737-2

I'm not familiar with USP 71 so I can't offer a specific judgement.

An expert committee is responsible for ISO 11737-2. I wonder if their deliberations bear on the relationship between the two approaches, and in particular if the committee is on record as expressing an opinion about USP 71.

If you want to pursue this deep enough, you might consider contacting a member of that committee from your part of the world, to see if they can point you to documentation of the committee's development process for the current standard. I'd assume that USP 71, if it's similar in purpose and is older, must have been a starting point. I'd think it'd be critical to understand whether there was a divergence based on a substantive consideration, or instead the two documents are seen by the committee as essentially similar even though administratively independent.
 

Ajit Basrur

Leader
Admin
Re: Sterility Testing:- USP Chapter 71 and ISO 11737-2

1. Our contract laboratory not reviewed by the TGA. It operates under ISO 10725 and approved by us.

2. Our contract manufacturing facility is ISO 13485: 2003 certified by notified body. Our company has conformity assessment certificate issued by the TGA for the sterile product that we manufacture and distribute in Australia.

3. No microbiologist audited the laboratory either from notified body or through the TGA

I am getting serious after your questions, wouldn't be my approach of comparing USP 71 vs ISO 11737-2 valid to address the non-conformance, the TGA auditor kind of agreed on my approach at the closing meeting. Please let me know your feedback.

The ISO 11737-2 describes a modified sterility test specifically for the detection of aerobic organisms which have been exposed
to sub-lethal sterilization cycles.

This ISO sterility test method is recommended for the validation of both gamma and electron beam sterilization processes. ISO recommends that the sterility test be validated by using known sterile products. The method of choice for EO sterilized products is the official USP <71> procedure.

Refer Pharma Solutions, Testing & Development | Avista Pharma

Yes, you could compare both the sterility methods and evaluate the differences.
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Nash27

Involved In Discussions
Re: Sterility Testing:- USP Chapter 71 and ISO 11737-2

Dear Ajit,

Thanks for your comments, your explanation is much simpler and in line with my approach to address my question. Thanks for the White paper on sterility testing.
 
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