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Established in 2001, Puyang Zhong Yuan Restar Petroleum Equipment Co.,Ltd, “RSD” for short, is Henan’s high-tech enterprise with intellectual property advantages and independent legal person qualification. With registered capital of RMB 50 million, the Company has two subsidiaries-Henan Restar Separation Equipment Technology Co., Ltd We are mainly specialized in R&D, production and service of various intelligent separation and control systems in oil&gas drilling,engineering environmental protection and mining industries.We always take the lead in Chinese market shares of drilling fluid shale shaker for many years. Our products have been exported more than 20 countries and always extensively praised by customers. We are Class I network supplier of Sinopec,CNPC and CNOOC and registered supplier of ONGC, OIL India,KOC. High quality and international standard products make us gain many Large-scale drilling fluids recycling systems for Saudi Aramco and Gazprom projects.

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Out of Specification (OOS) Handling Procedure - Guidelines ...
Out of Specification (OOS) Handling Procedure - Guidelines ...

After investigation, if production process reveals that Out of Specification (OOS) is due to process error then reject the batch based on the finding and conclusion of the investigation and perform the impact analysis to identify any other batch of the same product or product manufactured in the same period is affected and close the Out of, Specification, (OOS) through and scientific justification in terms of the …

Out of Specification (OOS)- SOP and Formats - Pharma Beginners
Out of Specification (OOS)- SOP and Formats - Pharma Beginners

19 rows, · Out of ,Specification, (OOS): Test results that fall outside the established approved ...

(PDF) Handling of Out of Specification Results
(PDF) Handling of Out of Specification Results

The term OOS (out of specification), is defined as those results of in process or finished product testing, which falling out of specified limits, that are mentioned in compendia, drug master file,...

Out of Specification &Out of Trend Investigations (MHRA ...
Out of Specification &Out of Trend Investigations (MHRA ...

Out-of-Specification (OOS) Result –., Test result that does not comply with the pre-determined acceptance criteria, (i.e. for example, filed applications, drug master files, approved marketing submissions, or official compendia or internal acceptance criteria).

Out of specification (oos)1 - SlideShare
Out of specification (oos)1 - SlideShare

13/11/2014, · What is, Out of Specification, (OOS), The result obtained out of defined test limit, is called out of specification. USFDA guideline “Investigating Out of Specification (OOS) Test Results for Pharmaceutical Industry” Published by CDER in Oct 2006.

How to investigate Out of Specification (OOS) Laboratory ...
How to investigate Out of Specification (OOS) Laboratory ...

15/1/2015, · Out of specification implies test results which fall outside specifications or acceptance criteria established by the product manufacturer or the laboratory. Investigation of out of specification results Out of specification results can result from either of the two situations

Out Of Specification Investigations.
Out Of Specification Investigations.

• Investigations of "Out of ,Specification, (OOS) / Out of Trend (OOT)/ Atypical -results" have to be done in cases of:-Batch release testing and testing of starting materials.-In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on Certificates of Analysis.

Difference Between Out of Specification and Out of Trend ...
Difference Between Out of Specification and Out of Trend ...

25/8/2020, · ,OOS, (out of specification) is the comparison of one result versus, predetermin,ed specification criteria while OOT (Out of Trend) is the comparison of many historical data values versus time. 2., OOS, investigations focus on determining the truth about that one value while OOT investigations focus on understanding non-random changes.

SOP for Handling Out of Specification (OOS)
SOP for Handling Out of Specification (OOS)

The result which does not meet the pre-established specification of the test product shall be termed as OOS (out of Specification) result. Evaluation samples: Samples, which are of deviation batch, recovery batch, market complaint, pre-shipment sample, study and trial purpose.

Out of Specification (OOS) and Out of Trend (OOT)
Out of Specification (OOS) and Out of Trend (OOT)

Out of specification (OOS) is defined as a result that falls outside the predetermined specifications or established acceptance criteria set by the manufacturer and/or the laboratory. In simple terms, the result of a stability test conducted by a Quality Analyst (QA) should always adhere to the previously established specifications or criteria.

Out of specification shravan - SlideShare
Out of specification shravan - SlideShare

12/9/2015, · 1. 1 Out of Specification By: Shravan Kumar 2. 2 Definition If the analytical result (s) of a batch or material is/are falling out side of the established specification ranges, is called / considered as Out of Specification. Or The term OOS test results includes all suspect results that fall outside the predetermined Specification

Out-of-specification(OOS)  FDA Guidance - Lab ...
Out-of-specification(OOS) FDA Guidance - Lab ...

An explicit set of requirements is called, specification, and typically it needs to be satisfied by a material, product, or service. So when a material, product or service fail to meet one or more of the applicable specifications, it is referred to as being, out of specification,, abbreviated as OOS. FDA Guidance on OOS . FDA Requires that

Management of Out of Specification (OOS) for Finished Product
Management of Out of Specification (OOS) for Finished Product

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 industries and such fields as environmental and/or food

Out of Specification definition - Law Insider
Out of Specification definition - Law Insider

Out of Specification. definition. Out of Specification. (OOS) shall mean, a result that falls outside of the test’s acceptance criteria, (e.g. criteria established in filed applications, approved marketing submissions, official compendia, or by the manufacturer or the customer).

Possible Causes of Out of Specification : Pharmaceutical ...
Possible Causes of Out of Specification : Pharmaceutical ...

3/12/2020, · Out of specification is, the deviation of the product from the pre-determined specification., It means when a product is unable to meet the predefined limits for that particular product. There are various possibilities that may be responsible for these deviations.

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