Pharmaceutical Quality Systems

Bouwman-Boer, Yvonne; Andersen, Lilli Møller

doi:10.1007/978-3-319-15814-3_35

Cited by 4 publications

(2 citation statements)

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“…• недостаточная вовлеченность персонала в идеологию ФСК и ее внедрение на производстве (под вовлеченностью следует понимать комплексный показатель, замеряющий состояние корпоративной культуры компании и потенциал ее развития за счет неравнодушия персонала к своей работе и к делам компании, в которой они работают [6]). Не выделяя ни одной из перечисленных проблем приоритета, предлагаем рассмотреть вопросы, связанные с вовлеченностью персонала во внедрение ФСК, поскольку, как показывают релевантные научные исследования [7][8][9], через инструментарий вовлеченности можно решить задачи мотивации, индивидуальной и коллективной ответственности, повышения качества проходимого обучения и повышения квалификации персонала и др.…”

Section: результаты и обсуждениеunclassified

Guidelines for Promoting the Implementation of Pharmaceutical Quality Systems at EAEU Enterprises Through the Management of the Engagement of Production Personnel

Смирнов

Горячкин

Шестаков

et al. 2021

Razrabotka i registraciâ lekarstvennyh sredstv

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Introduction. The publication is devoted to the topical organizational and personnel issues of the implementation of the pharmaceutical quality system (PQS). The relevance of the study is due to the high importance of quality assurance in the development, production and release of drugs into circulation.Aim. The aim: to develop guidelines for organizational and personnel assistance in the implementation of pharmaceutical quality systems at enterprises of the Eurasian Union (EAEU) for the production of medicines (drugs) through the toolkit for engaging production personnel in the development of PQS.Materials and methods. Personnel engagement was assessed based on the engagement index; the benchmarking method was used when studying the impact of the engagement of production personnel on the economic indicators of corporate development (indicators of engagement and related economic indicators of “Akrikhin”, “Ozon” were compared with a panel of similar indicators for 12 pharmaceutical enterprises of the EAEU).Results and discussion. The important role of ensuring an increase in the engagement of production personnel in the development of PQS as a tool for sustainable provision of the effectiveness of the implementation of PQS and standards of good manufacturing practice (GMP) at drug production enterprises is stated. Taking into account the experience of forming quality circles in classical Japanese management, an innovative toolkit for managing the engagement of production personnel is proposed, based on the formation of employee communities, coordination and management of their engagement and development through the corporate portal of a pharmaceutical enterprise, as well as membership in closed clubs of ‘quality leaders’.Conclusion. Management of communities (small groups) of production workers is considered as a tool for improving the organizational and personnel support for the implementation and improvement of PQS / GMP at the EAEU pharmaceutical manufacturers. Through the communities, it is proposed to simultaneously manage the engagement, loyalty and job satisfaction of production personnel; community members, through the exchange of best manufacturing practices, ideas and opinions on the development of PQS and the improvement of nuclear quality assurance practices, will stimulate themselves and other production workers to consistently ensure the quality of manufactured drugs. The expected result is a steady increase in the quality of manufactured drugs, adherence of production personnel to the quality philosophy, creation of conditions for the growth of labour productivity of production personnel of pharmaceutical enterprises.

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Section: результаты и обсуждениеunclassified

Guidelines for Promoting the Implementation of Pharmaceutical Quality Systems at EAEU Enterprises Through the Management of the Engagement of Production Personnel

Смирнов

Горячкин

Шестаков

et al. 2021

Razrabotka i registraciâ lekarstvennyh sredstv

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“…Additionally, for observing follow-up activities, it is important to use a system for corrective and preventive actions. 19 Microbiological controls are an important part of the overall assurance of product quality. 20 Unfortunately, except for glove prints, we did not find a correlation between process improvement (lower cumulative RPN) and the results of microbiological controls.…”

Section: Original Researchmentioning

confidence: 99%

Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part C: applying risk assessment and risk control in practice

et al. 2021

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Objectives To describe the application of the model described in part A and part B of this series of articles for risk assessment (RA) and risk control (RC) of non-sterility during aseptic handling. The model was applied in nine hospital pharmacies. Methods The starting point was an audit of each hospital pharmacy. The determined risk reduction and remaining risks were entered into a risk assessment model. The corresponding risk prioritisation numbers (RPNs) for each source of risk were calculated and these values were summed up to a cumulative RPN. Subsequently, all hospital pharmacies started an improvement programme, using the risk assessment as input. Results of aseptic process simulation (APS) and microbiological monitoring (MM) were also collected. The participants were informed about their progress of risk reduction and results of APS and MM during the study period. At the end of the study (about 4 years after the start), a final assessment was executed by using a checklist with risk reducing measures for each source of risk. Additional risk reduction and remaining risks were put in an RA and RC template and corresponding RPN values and a new cumulative RPN were determined. Results At the start of the study differences in cumulative RPN values were relatively small (from 630 to 825). At the end they were relatively great (from 230 to 725), which illustrates a different sense of urgency for reducing the risk of non-sterility. Of all the risk reducing measures, a yearly audit of all operators had the greatest impact on reducing the risk of non-sterility. Except for glove prints, there was no correlation between process improvement (lower cumulative RPN) and results of microbiological controls. Conclusion A systematic and science-based reduction of the risks of non-sterility can be done by using a checklist with risk reducing measures and an RA & RC template. Prospectively, the relevance of each risk reducing measure can be demonstrated by RPN calculations. Microbiological controls are an important part of the overall assurance of product quality. However, the results are less useful for assessing the risk of non-sterility.

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A Complete Roadmap of Analytical Quality by Design in Various Analytical Techniques

Nagarajan¹,

Santhanam²,

Ponraj³

et al. 2023

CPA

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Background: For the development of robust analytical methods, Analytical-Quality-by-Design (AQbD)-based testing methods have been found to be more suited than other one factorial approaches. By creating a Method Operable Design Space, this strategy selects the optimal method conditions using the appropriate Design of Experiments. Objective: To impart knowledge to the researchers producing methods using this technique, this review seeks to provide an overview of the Analytical Quality-by-Design technique, experimental designs used, and a survey on methods developed using this technique in various analytical instruments. Method: The following parts must typically be accomplished for the method to be developed utilizing the Analytical Quality by Design technique: analytical target profile, scouting and risk assessment, experimental runs, selection of Method Operable Design Region, robustness testing, and validation. To optimize the risk parameters, suitable designs for the experiment were chosen based on the number of variables that needed to be optimized. Conclusion: By establishing a relationship between the high-risk factors and target profiles utilizing multidimensional design space, robustness and other critical quality attributes in techniques were attained with a minimum of experimental runs, analytical time, and energy. So, it stands to reason that the Analytical Quality by Design technique will soon be widely used and highly advantageous in several industries.

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Pharmaceutical Quality Systems

Cited by 4 publications

References 1 publication

Guidelines for Promoting the Implementation of Pharmaceutical Quality Systems at EAEU Enterprises Through the Management of the Engagement of Production Personnel

Guidelines for Promoting the Implementation of Pharmaceutical Quality Systems at EAEU Enterprises Through the Management of the Engagement of Production Personnel

Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part C: applying risk assessment and risk control in practice

A Complete Roadmap of Analytical Quality by Design in Various Analytical Techniques

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