Search results for: K. L. Clase

Authors: Mercy Okezue, Kari Clase, Stephen Byrn, Paddy Shivanand

Abstract:

Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.

Keywords: ISO/IEC 17025:2017, laboratory standards, quality control, WHO GPPQCL

Procedia PDF Downloads 197

Authors: Abigail Ekeigwe, Bethany McGowan, Loran C. Parker, Stephen Byrn, Kari L. Clase

Abstract:

There are growing calls in the literature to develop and implement competency-based regulatory sciences education (CBRSE) in sub-Saharan Africa to expand and create a pipeline of a competent workforce of regulatory scientists. A defined competence framework is an essential component in developing competency-based education. However, such a competence framework is not available for regulatory scientists in sub-Saharan Africa. The purpose of this research is to identify entry-level competencies for inclusion in a competency framework for regulatory scientists in sub-Saharan Africa as a first step in developing CBRSE. The team systematically reviewed the literature following the PRISMA guidelines for systematic reviews and based on a pre-registered protocol on Open Science Framework (OSF). The protocol has the search strategy and the inclusion and exclusion criteria for publications. All included publications were coded to identify entry-level competencies for regulatory scientists. The team deductively coded the publications included in the study using the 'framework synthesis' model for systematic literature review. The World Health Organization’s conceptualization of competence guided the review and thematic synthesis. Topic and thematic codings were done using NVivo 12™ software. Based on the search strategy in the protocol, 2345 publications were retrieved. Twenty-two (n=22) of the retrieved publications met all the inclusion criteria for the research. Topic and thematic coding of the publications yielded three main domains of competence: knowledge, skills, and enabling behaviors. The knowledge domain has three sub-domains: administrative, regulatory governance/framework, and scientific knowledge. The skills domain has two sub-domains: functional and technical skills. Identification of competencies is the primal step that serves as a bedrock for curriculum development and competency-based education. The competencies identified in this research will help policymakers, educators, institutions, and international development partners design and implement competence-based regulatory science education in sub-Saharan Africa, ultimately leading to access to safe, quality, and effective medical products.

Keywords: competence-based regulatory science education, competencies, systematic review, sub-Saharan Africa

Procedia PDF Downloads 195

Authors: M. A. Okezue, K. L. Clase, S. R. Byrn

Abstract:

The requirement for maintaining data integrity in laboratory operations is critical for regulatory compliance. Automation of procedures reduces incidence of human errors. Quality control laboratories located in low-income economies may face some barriers in attempts to automate their processes. Since data from quality control tests on pharmaceutical products are used in making regulatory decisions, it is important that laboratory reports are accurate and reliable. Zinc Sulphate (ZnSO₄) tablets is used in treatment of diarrhea in pediatric population, and as an adjunct therapy for COVID-19 regimen. Unfortunately, zinc content in these formulations is determined titrimetrically; a manual analytical procedure. The assay for ZnSO4 tablets involves time-consuming steps that contain mathematical formulae prone to calculation errors. To achieve consistency, save costs, and improve data integrity, validated spreadsheets were developed to simplify the two critical steps in the analysis of ZnSO4 tablets: standardization of 0.1M Sodium Edetate (EDTA) solution, and the complexometric titration assay procedure. The assay method in the United States Pharmacopoeia was used to create a process flow for ZnSO₄ tablets. For each step in the process, different formulae were input into two spreadsheets to automate calculations. Further checks were created within the automated system to ensure validity of replicate analysis in titrimetric procedures. Validations were conducted using five data sets of manually computed assay results. The acceptance criteria set for the protocol were met. Significant p-values (p < 0.05, α = 0.05, at 95% Confidence Interval) were obtained from students’ t-test evaluation of the mean values for manual-calculated and spreadsheet results at all levels of the analysis flow. Right-first-time analysis and principles of data integrity were enhanced by use of the validated spreadsheet calculators in titrimetric evaluations of ZnSO₄ tablets. Human errors were minimized in calculations when procedures were automated in quality control laboratories. The assay procedure for the formulation was achieved in a time-efficient manner with greater level of accuracy. This project is expected to promote cost savings for laboratory business models.

Keywords: data integrity, spreadsheets, titrimetry, validation, zinc sulphate tablets

Procedia PDF Downloads 169