Recipe control in manufacturing system

Now a day’s regulators looking for control on the product /system recipe. Recipes  are very critical part of process. Because process are control through validated recipe. If firm calming that their system complying 21 CFR par 11/EU annex 11, in that case they should ensure that their system is capable for following mentioned control,

       a)      System should available with the audit trial and it should capture in case any change in individual recipe

      b)      Recipe edition, modification and deletion to be assign to only administrator, these mentioned options should not accessible to other authorization level.

Design, Operation, Qualification and maintenance of Isolator

Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half-suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling.