A review and analysis of product recall for pharmaceutical drug product

Miglani, Ashish; Saini, Chandan; Musyuni, Pankaj; Aggarwal, Geeta

doi:10.1177/17411343211033887

Cited by 6 publications

(5 citation statements)

References 12 publications

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“…When implementing any change or variation type or CI, there is always fear that a quality defect may occur which needs to be reported or recalled in a formal recall (all regulatory jurisdictions have a form of recall procedures and processes). Recalls create unwanted attention on the manufacturer by the regulatory authorities and create a loss of revenue and increased workload and resources in providing regulatory root cause and corrective actions (RCCA) [30]. The financial implication of drug recalls also are substantial.…”

Section: Pharmaceutical Industry and Regulatory Backgroundmentioning

confidence: 99%

Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

et al. 2021

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This study aims to investigate the barriers that exist when implementing continuous improvement methodologies, such as Lean Six Sigma (LSS), within the Irish Pharma industry. The main finding of this study is that 45% of participants perceived that a highly regulated environment could be a barrier to continuous improvement implementation, while 97% of respondents utilised Continuous improvement (CI) methods, such as Lean, Six Sigma, and LSS, within their organisations. While the International Conference of Harmonisation integrates CI into its Pharmaceutical Quality Systems (PQS) regulations, the highest motivation for CI implementation amongst the Irish Pharma industry is to improve Productivity and Quality. The main obstacles highlighted for CI implementation in Pharma attributed to stringent regulatory regimes were fear of extra validation activity, a compliance versus quality culture, and a regulatory culture of being “safe”. Another relevant finding presented in this paper is that participants CI LSS tools are very strongly integrated into the pharma industries corrective and preventative action system, deviations, and internal audit systems. Limitations of the research are that all the data collected in the survey came from professionals working for multinational Pharmaceutical companies based in Ireland. The authors understand that this is the first research focused on the barriers and status of CI initiatives in the pharmaceutical industry. The results of this study represent an important step towards understanding the enablers and obstacles for the use of continuous improvement methodologies in pharmaceutical manufacturing industries on a global scale.

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Section: Pharmaceutical Industry and Regulatory Backgroundmentioning

confidence: 99%

Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

et al. 2021

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“…Consumer level: Patient and other customers, as well as retail and wholesale-built level, are all included in the consumer-based level. 4,5 Procedure of product recall as per USFDA As early as a report about a noncompliance which has the tendency to mark severe to moderate health care damage is obtained, a drug recall process will just be initiated. One of most prevalent causes of complaint is still the FORM-483.…”

Section: Classification Of Recallmentioning

confidence: 99%

“…Monitor and inspecting the recall -FDA develops and implements a recall audit plan to guarantee that recall is functional. [5]. The US Food and Drug Administration (USFDA) determines whenever a recall must be called off.…”

Section: Official Action Indicated (Oai) 2 Volunteer Action Indicated...mentioning

confidence: 99%

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A retrospective analysis on the product recall due to solvent and mineral residue issues

Ahmed

Musyuni

Aggarwal

2022

Journal of Generic Medicines

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Drug recalls are essential to maintaining the safety process because the medical industry’s top objective is primarily to deliver higher-quality goods to a larger population. They do this by eliminating subpar products from the market. Drug recalls are increasing quickly as a result of increased investigation rates, the emergence of industrialization and the online era into the sector, and regulatory authorities and health experts are now focusing on more stringent regulations to prevent further recalls of faulty pharmaceutical drugs. The purpose of the present write-up is to give an overview of how drug recalls work with the help pf examples of recalls due to presence of undesired solvents and mineral residue, how they affect the pharmaceutical business, and what can be done to stop them.

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“…In fact, various Bcc contaminated FPPs have been reported as the cause of several serious healthcare associated infection outbreaks across multiple healthcare settings [ 6 , 16 ]. Moreover, the consequences of Bcc contamination in FPPs can result in company associated financial loss and reputational damage [ 17 ]. Over the last ten years, we estimate that at least 50 pharmaceutical companies worldwide have been impacted by Bcc contamination FPP recall related events [ 18 – 20 ].…”

Section: Introductionmentioning

confidence: 99%

A culture-independent nucleic acid diagnostics method for use in the detection and quantification of Burkholderia cepacia complex contamination in aqueous finished pharmaceutical products

Duong,

Minogue,

Fullbrook

et al. 2024

PLoS ONE

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The Burkholderia cepacia complex (Bcc) is the number one bacterial complex associated with contaminated Finished Pharmaceutical Products (FPPs). This has resulted in multiple healthcare related infection morbidity and mortality events in conjunction with significant FPP recalls globally. Current microbiological quality control of FPPs before release for distribution depends on lengthy, laborious, non-specific, traditional culture-dependent methods which lack sensitivity. Here, we present the development of a culture-independent Bcc Nucleic Acid Diagnostic (NAD) method for detecting Bcc contaminants associated with Over-The-Counter aqueous FPPs. The culture-independent Bcc NAD method was validated to be specific for detecting Bcc at different contamination levels from spiked aqueous FPPs. The accuracy in Bcc quantitative measurements was achieved by the high degree of Bcc recovery from aqueous FPPs. The low variation observed between several repeated Bcc quantitative measurements further demonstrated the precision of Bcc quantification in FPPs. The robustness of the culture-independent Bcc NAD method was determined when its accuracy and precision were not significantly affected during testing of numerous aqueous FPP types with different ingredient matrices, antimicrobial preservative components and routes of administration. The culture-independent Bcc NAD method showed an ability to detect Bcc in spiked aqueous FPPs at a concentration of 20 Bcc CFU/mL. The rapid (≤ 4 hours from sample in to result out), robust, culture-independent Bcc NAD method presented provides rigorous test specificity, accuracy, precision, and sensitivity. This method, validated with equivalence to ISO standard ISO/TS 12869:2019, can be a valuable diagnostic tool in supporting microbiological quality control procedures to aid the pharmaceutical industry in preventing Bcc contamination of aqueous FPPs for consumer safety.

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A review and analysis of product recall for pharmaceutical drug product

Cited by 6 publications

References 12 publications

Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

A retrospective analysis on the product recall due to solvent and mineral residue issues

A culture-independent nucleic acid diagnostics method for use in the detection and quantification of Burkholderia cepacia complex contamination in aqueous finished pharmaceutical products

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