FDA Guidelines-For Out of Specifications (OOS) In Industries

N.Vishal Gupta et al /Int.J.PharmTech Res.2013,5(3) 945 Under these systems key elements are found and they are discussed. When an element correlate with the current good manufacturing practices requirement that element associated will be noted.

  Guidelines, Specification, Industreis, Guidelines for out of specifications, In industries

Management of Out of Specification (OOS) for Finished Product

Ravi et al. / Management of Out… IJPCR, Volume 9, Issue 3: March 2017 Page 223 Identifying and assessing OOS test results Phase I: laboratory investigation FDA …