Project Title:

literature review of stability and frequency of quality control samples (12000 words

Brief:

One of the main quality assessment methods in a medical laboratory is External Quality Assessment schemes (EQA). The leading EQA provider in the UK is the UK NEQAS (the United Kingdom National External Quality Assessment Service) that provides EQA schemes, particularly in laboratories and related disciplines across the UK. EQA use in describing a method that facilitates the comparison of laboratory testing quality to an outside laboratory source. Participation in EQA programs provides valuable information that allows for the comparison of results and performance among various test sites. EQA provides advance warnings for any systemic problems related to operations or kits. It additionally includes evidence about testing quality and indicates areas which require improvement. EQA assists in ensuring that customers, including health authorities, patients and physicians that a laboratory is capable of producing reliable results. EQA participation is essential in helping the evaluation of the reliability of materials, methods and equipment along with evaluation and monitoring training impact. There are Several EQA methods or processes are commonly used. These include:  Proficiency testing—external provider sends unknown samples for testing to a set of laboratories, and the results of all laboratories are analysed, compared and reported to the laboratories. Unknown sample, which is External Quality Control Sample sending by an external provider. Chemical stability of control sample molecules is a matter of great concern as it affects the accuracy and efficacy of the test. The requirement of stability testing data to understand how the quality of a control substance and product changes with time under the influence of various factors. Knowledge of the stability of the molecule helps in selecting proper formulation and package as well as providing adequate storage conditions and shelf life, which is essential for regulatory documentation. The stability of sample does not mean “fix” or “not likely change”, but it means “controlled and acceptable change”. Stability testing is performed for the welfare of the patient and to protect the reputation of the producer, as a requirement of regulatory agencies to provide data that may be of value in formulation of other product.

Forced degradation can be studied to determine the stability of the molecule, and it is a process that involves degradation of sample control products and control substances at conditions more severe than accelerated conditions and thus generates degradation products. Although forced degradation studies are a regulatory requirement and scientific necessity during control or test development, it is not considered as a requirement for a formal stability program. Such application is expected to contain a “full description of the sample substance including its physical and chemical characteristics and stability as well; such specifications and analytical methods are necessary to assure the identity, strength, quality, purity and bioavailability of control product and stability data with a proposed expiration date.This review provides a proposal on the literature of control sample stability and its application for the development of the frequency. Accordingly, the purpose of this write-up is to suggest a proper frequency for the EQA sample that should meet the quality requirements. Some other aspects, like suitability of monthly or quarterly frequency of biochemistry analytes, should be covered.

The discussion also touches upon various critical issues, such as the cost of the EQA scheme and how the proper frequency can play a role on the budget which are important with respect to the development of quality.

 

What is the purpose of the project?

1- Evaluate the stability of external quality control sample which is distributed by an external quality assessment laboratory.

2- Assess the appropriateness of the frequency or infrequency of external quality assessment samples for quality assurance of laboratories.

3- Determine the effect of the frequency of EQA and evaluate of performance may have on patient result accuracy and reliability.

4-Detect the area of improvement and the impact of frequency on laboratory performance which will make beneficial to lab result in term of quality and reliable service.

OBJECTIVE OF STABILITY STUDIES

Stability study is demonstrating the shelf life and storage condition of the control product

-To provide evidence from the literature on how much quality of a control sample with time under the influence of the variety of environmental factor and storage condition such as temperature, humidity and light.

-The study can also provide information about the degradation pathway of

products that could form during storage.

– Demonstrate the stability indicating the power of the analytical procedures applied.

What are the planned or desired outcomes?

– Evaluate the stability of the EQA sample.

– Evaluate the accuracy of the controls upon stability-evaluate the frequency or infrequency of some laboratory analytical external quality assessment send out to laboratories for analysis based on stability of EQA sample.
– Detect the area of improvement and the impact of frequency on laboratory performance.
-Suggest a proper frequency for the EQA sample depend on the control stability


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