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?
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?