DETAILS, FICTION AND API MANUFACTURING

174. Two responses stated that proposed Sec. 820.122 Storage really should be amended for being similar to ISO 9001, and that the remainder of the necessities should be deleted and included in a steerage doc. A single comment said that the phrase ``obsolete'' should be deleted for the reason that, Whilst a device may perhaps now not be bought, thus

similar product failures because neither medical professionals nor customers have all of the knowledge required to make suitable judgments of item excellent and legal tort therapies are slow, inefficient, and very highly-priced. The changes towards the CGMP regulation will require manufacturers to extend [Site 52644] their quality systems to incorp