Pharmaceutical Quality Audits: A Review

Agarwal, Princy; Mishra, Abha

doi:10.22159/ijap.2019v11i1.29709

Cited by 10 publications

(7 citation statements)

References 1 publication

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“…The documentation of the ethnobotanical approach is an improvement for enhancing the understanding of native knowledge systems [27,28]. The present trends for surviving healthy long life entirely dependent on the traditional medicines and it possesses several natural constituents to eliminate the critical causes of the disease [29,30]. Plants are a rich source of free radical scavenging molecules such as terpenoids, vitamins, lignins, phenolic acids, flavonoids, tannins, quinones, alkaloids, coumarins, betalains, amines, and other metabolites which are rich in antioxidant property.…”

Section: Discussionmentioning

confidence: 99%

An Ethnobotanical Study of Wild Medicinal Plants Used by Migratory Shepherds – A Tribal Community of Western Himalayas

Radha

Puri

Kumar

2019

Asian J Pharm Clin Res

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Objectives: Migratory shepherds of Kinnaur, Shimla, and Sirmaur districts in Himachal Pradesh of the western Himalayas have rich traditional knowledge of medicinal plants and its uses, in this respect; an ethnobotanical survey was carried out from 2017 to 2018. Methods: The required information on ethnomedicines used by tribal migratory shepherds was collected through personal field visits, interview method and using a pretested questionnaire. Results: It was observed that in all 78 species were used by shepherds en route from high hills to low hills. In high hills 35 species, in mid hills 20 species, and low hills 23 species were found to be used as ethnomedicine source. Conclusion: This study shows that shepherds in tribal areas are highly dependent on ethnobotanical remedies, which evolved over generations of experience and practices, for health care. The common diseases were treated by ethnomedicinal plants such as cough, cold, body pain, Skin infection, wounds, diarrhea, respiratory problems, and sunburn. The collected detailed information on the list of plants and their therapeutic practices among tribal migratory shepherds may be helpful to improve the future pharmaceutical applications.

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Section: Discussionmentioning

confidence: 99%

An Ethnobotanical Study of Wild Medicinal Plants Used by Migratory Shepherds – A Tribal Community of Western Himalayas

Radha

Puri

Kumar

2019

Asian J Pharm Clin Res

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“…The first step towards the customer focus is to meet the regulatory and the statutory requirements along with the customer requirements. One of the main benefits of the ISO Quality System is to implement the regulatory and the statutory requirements for improving the effectiveness of processes and services 10,11 .…”

Section: Vendor Evaluation Criteriamentioning

confidence: 99%

A Short Review on Vendor Evaluation, Approach, Criteria and Questionnaire

Mullaivendan

Morais

2022

Int J Life Sci Pharm Res

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Vendor evaluation, a part of the cGMP which is used to ensure the procured products from the vendors,are meeting their quality standards. To avoid the procurement of substandard products from vendors, it is necessary to qualify the vendor / supplier which can avoid the adverse effect on the quality standards, regulatory requirements, and safety of the patients. The main objective of this review paper is to provide an overall outline of the vendor evaluation and to avoid quality failure and promote patient safety. This review paper covers the methods and criteria for evaluating of vendors in the pharmaceutical industry. This paper focuses on vendor evaluation by questionnaire to meet current Good Manufacturing Practice (cGMP). This text reviews the practical challenges faced and strategic plans of the pharmaceutical industry to achieve compliance management and the quality standards of products. An overview of the methods and approaches followed by the pharmaceutical industry to meet the regulatory requirements which were proposed by the leading regulatory bodies like the US Food and Drug Administration (USFDA) and European Medicines Agency (EMA) is briefly described. Most of the studies focus on criteria and methods, but rarely on approaches and questionnaires. Study includes the approaches, methods, criteria and questionnaire to achieve the quality and regulatory compliance and also emphasizes the vendor to stay confident on quality and the compliance of their products produced. The key points on the vendor questionnaire were effectively discussed, which remains the most common and effective method of vendor evaluation. This review paper also helps the professionals to arrive at an overall outline about the vendor evaluation aspects and questionnaire. The outcome of the study shows the importance of vendor evaluation, which helps in supply chain management. , , , .

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“…The results of an audit will assist in improving the process and establishing a better system for the benefit of the organization. An audit will evaluate the strengths and weaknesses of quality assurance methods [2]. Pharmaceutical audits cover procedures for performance qualification up to design qualification.…”

Section: Introductionmentioning

confidence: 99%

Pharmaceutical Audit Process, Outcomes, and Implications–overview

R. K.,

MISHRA,

et al. 2024

Int J Pharm Pharm Sci

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The audit process is a crucial component of regulatory compliance and quality assurance in both the United States of America (USA) and the European Union (EU). This review paper compares and analyses the audit processes, results, and ramifications in these two important markets. The study investigates how pharmaceutical audits affect patients’ trust, market stability, and profitability of a company while highlighting the need for adherence to quality standards. Data integrity, supply chain complexity, and adherence to exacting quality standards are just a few of the notable difficulties faced by auditors in the USA and EU. There is a need to have a strong pharmacovigilance system as well to guarantee the security and effectiveness of pharmaceutical products for patients. This study can be useful reference material for stakeholders, decision-makers, and companies looking to increase accountability, reduce risks, and uphold the integrity of a firm’s operations in the global market. A thorough analysis of audit procedures in the USA and EU will facilitate in promotion of effective and efficient manufacturing, control, and distribution of pharmaceutical products while boosting confidence among patients and in the healthcare system as a whole.

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Pharmaceutical Quality Audits: A Review

Cited by 10 publications

References 1 publication

An Ethnobotanical Study of Wild Medicinal Plants Used by Migratory Shepherds – A Tribal Community of Western Himalayas

An Ethnobotanical Study of Wild Medicinal Plants Used by Migratory Shepherds – A Tribal Community of Western Himalayas

A Short Review on Vendor Evaluation, Approach, Criteria and Questionnaire

Pharmaceutical Audit Process, Outcomes, and Implications–overview

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