FDA expects corporations to have written procedures (SOP’s) and descriptions of the cleansing processes used for various items of equipment. Suppose corporations have a cleaning procedure for cleaning between different batches of an equivalent product and use a unique method for cleaning product ...

Pharmaceutical product contaminate pharmaceutical products; by a being, improvement agents, or different materials. In several cases, it should flow from to the perennial use of an equivalent instrumentation for process. To avoid contamination issues office introduced improvement methodology validation ...

The Food and Drug Administration states that cleaning equipment before use is nothing new, so the 1963 GMP regulation (Part 133.4) declares that “equipment shall be kept very clean and orderly.” A similar section for instrumentation cleansing (211.67) was included in the 1978 CGMP rule. Of ...