CONSIDERATIONS TO KNOW ABOUT API PHARMACEUTICAL

174. Two remarks mentioned that proposed Sec. 820.122 Storage must be amended to become similar to ISO 9001, Which the remainder of the requirements really should be deleted and A part of a assistance doc. One particular comment mentioned the expression ``out of date'' ought to be deleted mainly because, Even though a tool may well not be sold, the

In addition they identify the Management strategy to successfully safeguard constant solution good quality. A audio process comprehending allows the conscious choice of verified acceptable ranges for reaction parameters and intermediate item top quality. It avoids overly slim parameter ranges or unneeded restricted intermediate solution specificat