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Forced Degradation (1) HPLC (8) ICH (12) Lifecycle (7) Method development (3) Methods (1) MTS (6) MTS Helpdesk (12) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (17) Verification (1) Video (5) Webinar (2)
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5 Golden Rules for Effective (and Inspection Ready) OOS Investigations
The investigation of out of specification (OOS) results is a regulatory requirement in a GMP laboratory and these investigations are intensively scrutinised by health authority inspectors. The purpose of this article is to provide 5 ‘Golden Rules’ which will make sure that investigations are both effective and inspection ready. Rather than use the term OOS…
Forced Degradation (1) HPLC (8) ICH (12) Lifecycle (7) Method development (3) Methods (1) MTS (6) MTS Helpdesk (12) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (17) Verification (1) Video (5) Webinar (2)