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Ongoing Stability Testing: Requirements, Solutions and ...
Guidelines (1) came into force in 2006; item 1.5 makes the annual Product Quality Review (PQR) compulsory ... specifications have to be observed. Thus, further ongoing ... in the case of out-of-specification (OOS) results and significant negative trends. If verified, they must be reported ...
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Management of Out of Specification (OOS) for Finished Product
impactfactor.orgthree categories OOS, OOT, Atypical results. The enquiry may vary with the object under investigation1. In pharmaceutical industry, out-of-specification (OOS) test results are results that (after rounding off) fall outside the specifications of established acceptance criteria. By analogy, measurement or test results obtained in other