scholarly journals PHARMACEUTICAL QUALITY AUDITS: A REVIEW

2019 ◽  
Vol 11 (1) ◽  
pp. 14
Author(s):  
Princy Agarwal ◽  
Amul Mishra
Keyword(s):  
Quality Assurance ◽  
Pharmaceutical Industry ◽  
Pharmaceutical Company ◽  
Search Engine ◽  
Quality System ◽  
Vital Function ◽  
Regulatory Requirements ◽  
Reimbursement Mechanisms ◽  
Quality Audit ◽  
Pharmaceutical Quality

Auditing is a vital function within a pharmaceutical company nowadays. Quality audit is a review and evaluation of all or part of a quality system with the specific purpose of improving it. It is one of the means to examine pharmacy programs and ensures that the procedures and reimbursement mechanisms comply with the contractual and regulatory requirements. A quality audit is usually conducted by external or independent experts or by a team designated by management for this purpose. These audits can be extended to suppliers and contractors as well. An audit will assess the strengths and weaknesses of quality assurance and quality assurance processes, the results of which assists in improving processes and building a better system for company benefits. This article focuses on various aspects of quality auditing in the pharmaceutical industry including its principles, objectives, importance and benefits and planning along with the deficiencies that are likely to occur during the process. This review comprises a well-organized summary of various guidelines available till date using the Google Scholar search engine and the keywords listed below.

scholarly journals ACHIEVING COMPETITIVE ADVANTAGE THROUGH PRACTICING TQM TOOLS IN PHARMACEUTICALS COMPANY

2014 ◽  
Vol 43 (2) ◽  
pp. 103-109
Author(s):  
Niamat Ullah Ibne Hossain ◽  
Farjana Nur ◽  
Md. Ahasan Habib
Keyword(s):  
Quality Assurance ◽  
Quality Improvement ◽  
Pharmaceutical Industry ◽  
Competitive Advantage ◽  
Pharmaceutical Company ◽  
Control Chart ◽  
Control Limit ◽  
Important Goal ◽  
Fishbone Diagram ◽  
Control Limits

In order to survive in a competitive market, improving quality and productivity of Product or processis a must for any company. And in case of pharmaceutical industry, effective quality assurance policyimplementation is the most important goal. The main objective of this paper is to apply the Total QualityManagement (TQM) tools in a pharmaceutical company and prove its advantage. Here Control Chart,Fishbone diagram, EWMA were used and the control limits were improved. This activity resulted in moreperfect control limit recommendations which actually capable of reducing the material cost. The TQMperspective views quality as the pivotal purpose of the organization. Present review attempts to furnish a wideoverview of the TQM tools leading to quality improvement of Pharmaceuticals Company.DOI: http://dx.doi.org/10.3329/jme.v43i2.17834

scholarly journals PROBLEMS OF MAKING QUALITY ASSURANCE DOCUMENTATION

2021 ◽  
Vol 93 (3) ◽  
pp. 5-13
Author(s):  
E. L. Alexandrova
Keyword(s):  
Quality Assurance ◽  
Quality Management System ◽  
Quality System ◽  
International Standards ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Pharmacy Organization ◽  
Pharmaceutical Quality System ◽  
Economic Union ◽  
The Republic

The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.

scholarly journals Situation of Pharmaceuticals in Albania 2014-2018

2020 ◽  
Vol 6 (2) ◽  
Author(s):  
Mallkuci I ◽  
Sinani N ◽  
Thereska I
Keyword(s):  
Pharmaceutical Industry ◽  
Marketing Authorization ◽  
Regulatory Requirements ◽  
Safety And Efficacy ◽  
Pharmaceutical Quality ◽  
Short Time

Background: Globally and locally the pharmaceutical industry is highly regulated. In Albania the regulatory requirements are changing with different amendments of Low and Regulations to ensure the supply with high pharmaceutical quality, safety and efficacy of medicines. The accelerated procedure for medicines that come from EU/FDA, has given to the patients access to new medicines such as orphans and biosimilars in a very short time from their first marketing authorization. In this way the patient can achieve new pharmaceuticals which are safe, efficient and qualitative and the most important point innovative medicines that are authorized for marketing in USA and EU.

scholarly journals Strategic account management as a value co-creation selling model in the pharmaceutical industry

2017 ◽  
Vol 32 (2) ◽  
pp. 310-325 ◽  
Author(s):  
Francois Pilon ◽  
Elias Hadjielias
Keyword(s):  
Pharmaceutical Industry ◽  
Pharmaceutical Company ◽  
Value Added ◽  
Pharmaceutical Companies ◽  
Design Data ◽  
Content Type ◽  
Qualitative Research Design ◽  
Account Management ◽  
A Value ◽  
Key Accounts

Purpose This study aims to explore the dynamics enabling strategic account management (SAM) to function as a value co-creation selling model in the pharmaceutical industry. Design/methodology/approach Using an inductive qualitative research design, data are collected within 11 industry customers in Canada. This work focuses on hospitals as strategic accounts of pharmaceutical companies, exploring SAM value co-creation in the “hospital-pharmaceutical company” relationship. Findings The findings suggest the presence of two key dimensions that can enable a value co-creation SAM model in the hospital-pharmaceutical relationship: “customer-tailored value-added initiatives” and “relationship enhancers”. Customer-tailored value-added initiatives explain the activities that are central to the hospital-pharmaceutical company relationship and can lead to the provision of value added that is unique to the hospital. Relationship enhancers explain the activities that can help strengthen hospital-pharmaceutical company relations in the pursuit of enhanced value-added interactions between the two parties. The research demonstrates a cyclical relationship between “customer-tailored value-added initiatives” and “relationship enhancers”, leading to value co-creation through a SAM model. Practical implications The study informs pharmaceutical industry practitioners on how to improve their value proposition through new, more sustainable selling practices. It offers information on implementing a value co-creation SAM model, which can enable pharmaceutical companies to sustain long-lasting value-added relationships with key accounts such as hospitals. Originality/value The study contributes to the field of SAM by conceptualizing SAM as a value co-creation system. It introduces new knowledge in pharmaceutical marketing by offering empirical insight on the applicability and use of SAM in the hospital-pharmaceutical company dyad.

Risk Management: How Not To Do It

2021 ◽  
Vol 27 (4) ◽  
Author(s):  
Siegfried Schmitt
Keyword(s):  
Risk Management ◽  
Best Practices ◽  
Quality System ◽  
Pharmaceutical Quality ◽  
Pharmaceutical Quality System

Regulations worldwide tell us that a Pharmaceutical Quality System has to be risk-based. In reviewing best practices and ICH Q9 guidelines on QRM, the author shares insights on what not to do, using examples the author has come across over the more than 30 years in industry.

scholarly journals COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA

2018 ◽  
Vol 3 (1) ◽  
pp. 75-87
Author(s):  
Dinesh Chandra Konuri ◽  
Mamillapalli S. ◽  
A. Elphine P. ◽  
Brahma S.R. Desu
Keyword(s):  
Pharmaceutical Industry ◽  
Comparative Study ◽  
Generic Drugs ◽  
Emerging Market ◽  
Generic Product ◽  
Regulatory Requirements ◽  
Registration Process ◽  
Regulated Markets ◽  
Device Agency ◽  
Japan And China

A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA. JAPAN and CHINA are two different markets which are important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world’s second largest pharmaceutical market. Whereas China is under the Emerging market, but unfortunately these two are un trapped markets in the Pharma hub. So, am enthusiastic to know about Regulatory considerations and Registration process of Generic Drugs.

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