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Re: identity testing(annex 8)
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Dear Safwa, To me this provision from EU-GMP means that the non-identification of every container received is possible only if the is absolutely no risk of confusion at the raw material facility. Therefore, when the pharmaceutical manufacturer audits the RM manufacturer this risk will be assessed for each product of interest. Most RM manufacturers are not "mono-product" then the audit report should clearly state that the RM of interest is at no risk of mix-up or confusion. Consequently the audit report of the accredited boday should state for the same. If it is a general assessment, let's say from an ISO 9000 point of view, then the information available is insufficient to reduced identification at receipt. To me again, you can only reduce the identification to certain containers only when the report you have (from the pharmaceutical manufacturer or from the accredited body) is clear on that risk for the considered product. Best regards, JDM |
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