2020年3月9日 · In the SOP, Detailed procedure provided for the handling of out of specification (OOS) test results, preliminary investigation, Phase I, Phase II and Phase III investigation, …

2021年2月17日 · Guideline for Handling of Out of Specification (OOS) results occurs during analysis of Raw Material and Pharmaceutical Drug Products (Different stages like – In …

2024年4月17日 · The purpose of this SOP (Standard Operating Procedure) is to describe the procedure for handling out of specification results obtained during analysis. This SOP is …

2022年5月20日 · SOP for Out of Specification (OOS) | Out of Specification Pharma | Out of Specification as per MHRA & USFDA Guidelines | OOS SOP Covers below points: Out of …

2023年12月1日 · This SOP is applicable for in case of OOS results in test “Dissolution” (After confirmation at stage criteria as per respective pharmacopeia (e.g. after S1, S2 and S3 level …

2023年1月2日 · OOS results observed during the following samples (method validation, method transfer, product development, vendor qualification, swab, organoleptic tests (like odor and …

2019年9月15日 · OOS全称“Out of specification”，即超出检验标准。 FDA、EU、WHO、ICH及中国GMP均对其有明确要求。 实验室调查应遵循真实、科学、有效的原则。 对于QC实验室每 …

2024年12月12日 · Learn how to write SOP for out of specification (OOS) investigations to ensure compliance, accuracy, and quality control in pharmaceutical laboratories.

2024年4月17日 · To lay down the procedure for handling of out of specification results in microbiological testing. It is applicable to handling and investigation of Out Of Specification …

2022年3月11日 · This SOP defines the procedure for investigation of all Out of Specification (OOS) test results. This SOP is applicable to testing of Raw Materials, In-process Control …