Sampling plan API
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Dear All Expertise !
Greetings, Hope you are well
Please help me to get the information about the sample plan that should be applied like required by GMP to identify (IR) an incoming API (1000 containers).
They are packaged as paper bag (1000 containers) we have sufficient justification to do it ( risk assessment, good history of 5years of IR identification analysis of 100% container, certified supplier)
should we do just identification when we will proceed by sampling plan if we have reduced test based on risks assessment, thanks a lot in advance
GMP Committee response
EU GMP Annex 6 states that “The identity of a complete batch of starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample.” It does go on to say that “It is permissible to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled.”, but the bar is very high for this, especially when the material concerned is the API. There are many examples of regulatory findings associated with inadequate assurance of starting materials. It is suggested that if you believe you have a sound justification, then you discuss this with your national competent authority. You should also consider the expectations of the competent authorities in countries to which the resultant product will be sent