scholarly journals Retrospective Study of Inspectors Competency in the Act of Writing GMP Inspection Report

2021 ◽  
Author(s):  
Chidi Uche ◽  
Zita Ekeocha ◽  
Stephen Robert Byrn ◽  
Kari L Clase
Keyword(s):  
Retrospective Study ◽  
Intervention Program ◽  
Quality Management System ◽  
Good Manufacturing Practice ◽  
Content Quality ◽  
Risk Levels ◽  
Report Writing ◽  
Regulatory Standards ◽  
Objective Evidence ◽  
Third Person

The research was a retrospective study of twenty-five Good Manufacturing Practice (GMP) inspection reports (from March 2017 through to December 2018) of a national medicine regulatory agency, drug Inspectorate, in West Africa, designed to assess the inspectors’ expertise in the act of inspection report writing. The investigation examined a paper-based tool of thirteen pre-registration Inspection reports and twelve GMP reassessment reports written prior and following an intervention program by external GMP trainers to enhance inspectors’ skill in pharmaceutical cGMP inspection. The study made use of quantitative analysis to investigate each team’s expertise in the act of writing GMP inspection report. Likewise, each report’s compliance with the requirements of three regulatory standards on GMP inspection report writing was ascertained. Impact of intervention program on lead inspectors’ competence was assessed. Lastly, gap in each team writing effectiveness, and lead inspectors’ abilities to deliver an effective report were determined. The results showed one of the inspection team (4.0%) wrote an excellent report. Two (8.0%) of the twenty-five inspection teams penned good inspection reports. Eleven (44.0%) teams drafted needs improvement reports and the remaining eleven teams (44.0%) prepared unacceptable reports. The excellent report and the two good reports had report format that meet expectation. One (50.0%) of the good reports showed the authors possess excellent knowledge of cGMP technical areas. The remain good report (50.0%) revealed the writers’ knowledge.as good. The excellent report showed the authors displayed partial mastery in the use of objective evidence while the two good reports disclosed theirs as having partial and evolving abilities. One of the teams (50.0%) that wrote good reports displayed good use of third person narrative past tense in report writing whereas the other team used the same tense and voice excellently. Generally, a sort of marginal level of performance was prominent among the inspection teams. A gap, if not tackled, will slow down regulatory process through increase report review, litigations that query report factual accuracy (AIHO, 2017) and delay in issuance of marketing authorization. In conclusion, trainings on quality attributes, such as technical content (Quality Management System (QMS) and Site), the use of objective evidence, assignment of risk levels to GMP violations and citing of applicable laws, regulation and guidelines that substantiate GMP observations, were recommended, to enhance knowledge sharing and regulators’ performance in the act of writing inspection report.

Motives for Secondary Social Sharing of Emotions

2008 ◽  
Vol 103 (1) ◽  
pp. 11-22 ◽  
Author(s):  
Véronique Christophe ◽  
Gérald Delelis ◽  
Pascal Antoine ◽  
Jean-Louis Nandrino
Keyword(s):  
Retrospective Study ◽  
Social Comparison ◽  
Emotional Support ◽  
High Intensity ◽  
Third Person ◽  
Negative Condition ◽  
Social Sharing ◽  
New Evidence ◽  
Social Sharing Of Emotions

This study provides new evidence of motives of secondary social sharing of emotions. In a retrospective study, 140 female ( Mage = 29.4 yr., SD=12.8) and 116 male ( Mage = 29.5 yr., SD=13.1) participants were asked to recall a recent situation in which they had talked to a third person about a positive or negative, low or high intensity emotional narrative they had heard. 70% of the respondents reported having secondarily shared the reported event rapidly after the narration with several persons and at several times. Moreover, they not only described the event, the speaker's reaction and their own reactions, but also revealed the identity of their first confidant. Participants reported having spread the emotional narrative more widely in the high negative condition in order to seek emotional support and social comparison.

Factors accounting for the ability of children with SLI to learn agreement morphemes in intervention

2008 ◽  
Vol 35 (1) ◽  
pp. 25-53 ◽  
Author(s):  
MONIKA PAWŁOWSKA ◽  
LAURENCE B. LEONARD ◽  
STEPHEN M. CAMARATA ◽  
BARBARA BROWN ◽  
MARY N. CAMARATA
Keyword(s):  
Language Impairment ◽  
Specific Language Impairment ◽  
Intervention Program ◽  
Regression Analyses ◽  
Specific Language ◽  
Wide Range ◽  
Verb Constructions ◽  
Two Factors ◽  
Third Person

ABSTRACTThe aim of this study was to uncover factors accounting for the ability of children with specific language impairment (SLI) to learn agreement morphemes in intervention. Twenty-five children with SLI who participated in a six-month intervention program focused on teaching third person singular -s or auxiliary is/are/was showed a wide range of use of the target morpheme after intervention. Regression analyses showed that age and two factors expected to be related to agreement – the use of noun plural -s and subject/verb constructions prior to intervention – significantly predicted progress in the acquisition of agreement morphemes. In contrast, the pretreatment use of morphemes hypothesized to be unrelated to agreement was not a significant predictor of progress. The results indicate that the ability of children with SLI to learn agreement morphemes relies on their prior ability to use noun plural and subject/verb constructions.

scholarly journals Experiences with the accreditation of the Institute for Medical Research and Occupational Health, Zagreb, Croatia

2020 ◽  
Vol 71 (4) ◽  
pp. 312-319
Author(s):  
Zdenko Franić ◽  
Tomislav Bituh ◽  
Ranka Godec ◽  
Mirjana Čačković ◽  
Tomislav Meštrović ◽  
...  
Keyword(s):  
Quality Management ◽  
Occupational Health ◽  
Medical Research ◽  
Radiation Protection ◽  
Management System ◽  
Quality Management System ◽  
Ambient Air ◽  
Objective Evidence ◽  
Accreditation Agency ◽  
Calibration Laboratories

AbstractAccreditation in accordance with the international General Requirements for the Competence of Testing and Calibration Laboratories (HRN EN ISO/IEC 17025 standard) has become a widely accepted method of quality management and objective evidence of technical competence, knowledge, and skills of testing and calibration laboratories. In 2010, the Institute for Medical Research and Occupational Health (IMROH) had its management system accredited against the HRN EN ISO/IEC 17025 standard for the following scopes: determination of radioactivity, testing of ambient air quality, and testing in the scope of ionising radiation protection. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In accordance with the rules of the Croatian Accreditation Agency, the second re-accreditation is due in 2020. This paper describes and discusses the quality management system at IMROH over the ten years of its implementation. We share our experiences about non-conformities discovered during regular work, internal audits, and external audits performed by the Croatian Accreditation Agency. The accredited management system significantly improved the performance of the accredited units, and the Institute increased its visibility and marketing advantage, consequently improving its market position.

CAPA: An important concept of Quality Assurance in Pharmaceutical Industry

2021 ◽  
pp. 357-362
Author(s):  
Chavan Pooja Ajit ◽  
Avinash Mahadeo Bhagwat ◽  
Atul Prabhakar Chaudhari
Keyword(s):  
Quality Management ◽  
Real Root ◽  
Quality Management System ◽  
Good Manufacturing Practice ◽  
Preventive Action ◽  
Customer Complaints ◽  
Root Cause ◽  
The People ◽  
Technical Capability ◽  
Made In

CAPA is used in the improvements to be made in product, process or quality system to eliminate non-conformities and other undesirable situation. CAPA could be regulatory concept that focuses on systematic investigations to search out the root cause, understanding and correcting discrepancies while attempting to avoid their reoccurrence. Instructions for a way they must be handled within the organization just in case of potential product problems, customer complaints or action to eliminate the cause of a detected nonconformities or incident. Regulatory inspections give more importance for CAPA, for the explanation, it will high light the systems followed within the company additionally because the technical capability of the people concerned. Changes proposed are to be verified and validated to confirm the effectiveness and quality attribution. CAPA is also an integrated part of ISO: 13485 and Good Manufacturing Practice (GMP) for medical products. The FDA defines the purpose of a CAPA procedure as: collecting and analyzing information, identifying and investigating product and quality problems, and taking appropriate and effective corrective and/or preventive action to prevent their recurrence. There is not a regulatory defined framework for the CAPA process only different requirements. The CAPA system investigation document will provide a clear picture of how the standard system works and hence, Regulatory Inspectors give lot of importance to audit this method. Real root cause is to be identified with scientific proof and which further may not be generated. This review provides comprehensive views on steps involved in corrective action and preventive action (CAPA), mechanism of taking CAPA enabling to boost the system of quality management. CAPA is a component of the overall quality management system. As per the FDA documents CAPA accounts for 30-50% of FDA-483 forms issued for noncompliance.

Programa de intervención breve de educación sexual desde el modelo biográfico en adolescentes de enseñanza secundaria: Un estudio piloto

2020 ◽  
Vol 31 (2) ◽  
pp. 38
Author(s):  
Antonio Ruiz García ◽  
Óliver Jiménez Jiménez ◽  
Miguel Ángel Rando Hurtado
Keyword(s):  
Sex Education ◽  
Group Dynamics ◽  
Intervention Program ◽  
Ad Hoc ◽  
Total Duration ◽  
Risk Behaviour ◽  
Public High School ◽  
Post Evaluation ◽  
Objective Evidence ◽  
Quasi Experimental

RESUMENLa educación sexual integral sigue siendo una asignatura pendiente en España, no viéndose privada de dificultades para su implantación y desarrollo en muchas ocasiones. Aunque existen iniciativas para la formación en esta área no todas ellas aportan evidencia objetiva de su efectividad. Por lo tanto, los objetivos del estudio fueron: Fomentar valores y actitudes abiertas sobre la actividad sexual (erotofilia), reducir mitos a la masturbación, mejorar las fantasías sexuales y aumentar los conocimientos y conductas de protección en las relaciones sexuales frente a ITS/VIH. Se realizó un diseño cuasi-experimental con evaluación pre-post en una muestra de 32 estudiantes de 4º de ESO de un instituto público de la provincia de Málaga, con 18 varones y 14 mujeres (M= 15.5; SD= .62). Se registraron datos sociodemográficos y de conductas sexuales de protección o riesgo, construido ad hoc, así como se aplicaron los cuestionarios EROS, SFQ, NAMI y ECI. La intervención se realizó en 4 sesiones, una por semana, con una duración total de un mes, siendo el contenido teórico-práctico de forma que mediante explicaciones, debates y dinámicas grupales se trabajaron los objetivos. Se han encontrado diferencias estadísticamente significativas tras la intervención. Por todo ello, un programa de intervención breve en educación sexual podría ser una herramienta relevante para la mejora de las actitudes y el conocimiento sexual de los adolescentes, siendo estos unos resultados prometedores para considerar las intervenciones orientadoras breves como una forma de mejorar las actitudes y conocimientos sexuales.ABSTRACT Comprehensive sex education continues to be a pending subject in Spain, not without difficulties for its implementation and development on many occasions. Although there are initiatives for training in this area, not all of them provide objective evidence of their effectiveness. Therefore, the objectives of the study were: to promote open values and attitudes about sexual activity (erotophilia), to reduce myths about masturbation, to improve sexual fantasies and to increase knowledge and protective behaviours in sexual relations against STI/HIV. A quasi-experimental design with pre-post evaluation was carried out in a sample of 32 students of 4th grade of ESO from a public high school in the province of Malaga, with 18 males and 14 females (M= 15.5; SD= .62). Sociodemographic and sexual protection or risk behaviour data were recorded, constructed ad hoc, as well as the EROS, SFQ, NAMI and ECI questionnaires. The intervention was carried out in 4 sessions, one per week, with a total duration of one month, being the theoretical and practical content so that through explanations, debates and group dynamics the objectives were worked on. Statistically significant differences were found after the intervention. Therefore, a brief intervention program in sexual education could be a relevant tool for the improvement of attitudes and sexual knowledge of adolescents, being these promising results to consider brief interventions as a way to improve sexual attitudes and knowledge.

scholarly journals AUTOMATED DOCUMENT MANAGEMENT SYSTEM OF PHARMACEUTICAL MANUFACTURER’S QUALITY MANAGEMENT SYSTEM IN ACCORDANCE WITH REQUIREMENTS OF GMP

2017 ◽  
Vol 72 (2) ◽  
pp. 126-133
Author(s):  
N. V. Pyatigorskaya ◽  
V. V. Beregovykh ◽  
Zh. I. Aladysheva ◽  
Vasiliy V. Belyaev ◽  
A. P. Meshkovskii ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Document Management ◽  
Document Management System ◽  
Pharmaceutical Quality System ◽  
Four Blocks ◽  
Pharmaceutical Production

Drugs must be produced in compliance with good manufacturing practice rules approved by an authorized federal agency. Pharmaceutical Quality System is a global requirement for development and production processes for pharmaceutical products. The article describes a variant of automated document management system of pharmaceutical manufacturer’s quality management system in accordance with current requirements of GMP. The peculiarity of the proposed system is the focuses on pharmaceutical production taking into account the characteristics and requirements for the pharmaceutical products production. All documents which are supposed to be used within the system are grouped into the four blocks: normative legal acts, core manufacturer standards according to GMP, regulatory documents, and register documents.

scholarly journals Analysis and critical review of ICH Q8, Q9 and Q10 from a generic pharmaceutical industry view point

2011 ◽  
Vol 57 ◽  
pp. 85-96
Author(s):  
Ljuba Karanakov ◽  
Jasmina Tonic-Ribarska ◽  
Marija Glavas-Dodov ◽  
Suzana Trajkovic-Jolevska
Keyword(s):  
Life Cycle ◽  
Quality Management ◽  
Quality Management System ◽  
Process Analytical Technology ◽  
Generic Medicine ◽  
Good Manufacturing Practice ◽  
Final Conclusion ◽  
Guidelines Implementation ◽  
Post Marketing ◽  
The Right

Generic industry aims to produce safe, efficient, built-in quality medicines that will satisfy patients’ requirements and will be competitive on the market. In this paper, assessment of the need for quality by design (QbD) and process analytical technology (PAT) implementation by generic industry was made, by analysis of the ICH Q8, Q9 and Q10 guidelines and their implementation in European regulation. The review of the guidelines indicates differences in the life cycle of a generic medicine, leading to a final conclusion in terms of generic industry. PAT provides statistical analysis and real time quality monitoring, as the basis for proactive quality management. Using QbD/PAT, quality is proved and improved throughout the entire life cycle. Better understanding of the product and processes within a defined design space leads to easier proof of built-in quality throughout the life cycle of the medicine, faster and easier regulatory evaluation, faster time to market, as well as post marketing savings regarding costs and time. Implementation of QbD/PAT as a systematic approach together with risk assessment as part of quality management system is a useful challenge to the generic industry and gives an opportunity for technological, temporal, financial and quality improvement. It was concluded that having in mind its’ own manufacturing capabilities the applicant should optimize the implementation of QbD in accordance with current good manufacturing practice guidelines. Implementation of QbD/PAT is an innovative challenge for the generic industry. Managing pharmaceutical quality system allows the top management to make right decisions at the right time.

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