Specifically, the guidance discusses how to investigate OOS test results, including the responsibilities of laboratory personnel, the laboratory phase of the investigation, additional testing...

2024年3月8日 · A confirmed out of specification (OOS) result leads to a non-conforming product. This article explores the key aspects of managing out-of-specification (OOS) results, distinguishing them from out-of-trend (OOT) findings, and detailing their regulatory origins.

2014年9月10日 · The OOS SOP respectively the draft of the OOT SOP contains the following definitions for the three terms: Out-of-Specification (OOS) Results A result that falls outside established acceptance criteria which have been established in official compendia and/or by company documentation.

In May 2022, the U.S. Food and Drug Administration (FDA) has published a new version (Revision 1) of its Guidance for Industry on Out-of-Specification (OOS) Results. The original version of the document was published almost 16 years ago, in October 2006.

2024年1月20日 · The following distinctions highlight how OOS, OOT, and OOE results each play a unique role in shaping QC practices, decision-making processes, and overall product quality management: Impact on Decision-Making. OOS: Directly influences critical decisions such as product rejection, rework, or recall. It often triggers immediate corrective actions.

response to Out of Specification (OOS) laboratory test results. 2 Scope and Applicability This Guideline applies whenever a laboratory test result is out of specification. It may apply to any laboratory, its joint ventures and licensees who operate to cGMP standards. Contract laboratories, performing GMP work, would be expected to follow

2024年2月4日 · This article covers the entire OOS process through the phases of OOS investigations, exploring its impact, the root causes and consequences of OOS results, and the strategies to prevent and address OOS situations.

Current good manufacturing practice for APIs includes the performance of scientifically sound raw material testing, in-process monitoring, release and stability testing, process validation, and...

Through this guide Pharma Quality Partners Ltd aims to provide the end-user with an understanding of the OOS/OOT methodology accepted by both the EU and US regulatory authorities. Are you confident that your PQS OOS/OOT processes meet expectations? Is the quality of your analytical data assured? Finding Regulatory Guidance?

2020年2月18日 · The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.