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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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OOS - Out of Specification for Pharmaceutical Industry ...
OOS - Out of Specification for Pharmaceutical Industry ...

Out of Specification The OOS results of the Samples include all test results that fall outside the specified Limits defined by the manufacturer in the drug applications, drug master files (DMFs). The Out of specification Results obtained in the Quality control Laboratory govern raw materials, packaging materials,, finished products, and stability samples according to company-specific parameters

Insights on Out of Specification ... - Pilgrim Quality
Insights on Out of Specification ... - Pilgrim Quality

The term Out of Specification is used by drug manufacturers to ensure that products are produced within the defined specifications. The Federal government compels drug manufacturers to adhere to testing regulations and guidelines to ensure that all of the drugs are produced according to …

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) | Atypical Laboratory Results ...
Out-of-Specification (OOS) | Atypical Laboratory Results ...

Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and how to apply it in laboratory situations. Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results.

Out of Specification Guidance - Update by MHRA - PharmaLex
Out of Specification Guidance - Update by MHRA - PharmaLex

The MHRA first published guidance to industry on how to handle ,Out Of Specification, (OOS) investigations in August 2013. It has recently been reviewed and improved for ease of use. When this guidance was released in 2013, it saw a shift in how OOS investigation were to be handled.

SOP on Handling of Out of Specification Results in quality ...
SOP on Handling of Out of Specification Results in quality ...

When an Out-Of-Specification test result is generated/ suspected, the analyst shall inform to the QA Manager immediately about the test results. OOS number shall be allocated in the following manner. OOS/YY/XXX, where OOS represent the Out of specification, YY indicates the last two digits of the year & XXX indicates the serial number from 001 to 999.

Out of Specification Guidance - MHRA Inspectorate
Out of Specification Guidance - MHRA Inspectorate

The issue faced when dealing with out of specification (OOS) results is as much a challenge now as it ever was. Without doubt the most common deficiency raised, is the one where the OOS result has...

Out of Specification - drugsformulations.com
Out of Specification - drugsformulations.com

5.1 All ,out-of-specification, test results (i.e. suspected test results that fall outside the established specifications or acceptance criteria) shall be investigated. 5.2 When an ,Out-Of-Specification, test result is generated/ suspected, the analyst shall inform to the QA Manager immediately about the test results.

Out Of Specification Investigations.
Out Of Specification Investigations.

• 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). • Test results that fall outside of established acceptance criteria which have been

Out Of Specification Investigations.
Out Of Specification Investigations.

• ,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). • Test results that fall outside of established acceptance criteria which have been

What is Out of-Specification Investigation and How to ...
What is Out of-Specification Investigation and How to ...

What is Out‑of-Specification (OOS): When analytical results that does not meets the pre-established acceptance criteria of in-house test specification or official pharmacopeial monograph specification range then it termed as Out‑of-Specification results.

Manual 058 Out of Specification Results Investigation
Manual 058 Out of Specification Results Investigation

trending, described in the guideline may be applicable to Out of Trend (OOT) results. 3 Definitions 3.1 Out of Specification (OOS) Test Result A laboratory test that is outside its regulatory or compendial limits. In some cases, there may be additional tests and/or limits that are used to assess the quality of a

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.

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

15/1/2015, · What is out of specification result? 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. Laboratory testing errors. Or

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

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