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Ultimately, if third parties happen to be involved in the development and qualification of analytical methods, a effectively-made technological transfer and correct documentation are demanded for retaining the qualification status following the transfer with the method and to allow the validation readiness evaluation training before ICH validation
PROCEDURE The test might be carried out either in five initial containers if adequate volume of products is on the market in each container and also the product or service container could be entered aseptically (i.e., needle and syringe via an elastomeric rubber stopper), or in 5 sterile, capped bacteriological containers of appropriate dimension i