established product /historical review pharm.

[Natuli]

Подскажите, пожалуйста, как перевести "established product" - давно представленный на рынке продукт? и "historical review" в :
DETAILED DESCRIPTION OF THE MANUFACTURING PROCESS
VALIDATION AND/OR EVALUATION
INTRODUCTION
Х is an established product and has been manufactured successfully by
У since 1999. To determine a rationale for the number of batches to be used
within the process validation phase, a historical review was performed of all manufactured
batches.
Х-таблетки
У -производитель

[Dimpassy]

да
+ хорошо известный

historical review - как-то описательно, например, анализ ранее полученных данных

[Natuli]

спасибо большое!

[delta]

+
Вариант для established
признанный