scholarly journals A Review on Regulatory Authorities & Standards Institutions and Self Auditing Consideration in Pharmaceutical Industry

2021 ◽  
Vol 11 (5) ◽  
Keyword(s):  
Pharmaceutical Industry ◽  
Regulatory Authority ◽  
Dosage Forms ◽  
Manufacturing Facility ◽  
Audit System ◽  
Regulatory Authorities ◽  
Human Use ◽  
And Performance ◽  
Iso 19011

In the pharmaceutical industry the course is designed to give you the skills that have taken many experienced auditors decades to develop. It follows the auditing guidance of ISO-19011 and is a virtual audit of a manufacturing facility that makes a range of dosage forms. This allows you to plan and prepare audits of the supplier and your own supplier audit system. Throughout the course, there is personal practice with exercises and teamwork’s in planning, preparation and performance that address WHO. The extensive of course notes and excellent lectures given by knowledgeable and professional tutors in pharmaceutical industry, The WHO was very easy to approach with any problems in during the course. The purpose of regulatory authorities to assess application for authorization to market products for human use and either grant authorizations to market each product or reject such applications and inspect the manufacturers and wholesalers of medicines for human use and either grant manufacturing and wholesale licenses or refuse such licenses. The international regulatory authorities under consideration are in this article WHO, USFDA, MHRA, and Australian TGA. The standard institutions give the economical background for development and transferring technologies, ISI, ISO, BISS and ASTM. Keywords: Regulatory authority, WHO, Self-auditing, Standard institution

3D PRINTING OF PHARMACEUTICALS – LEADING TREND IN PHARMACEUTICAL INDUSTRY AND FUTURE PERSPECTIVES

2020 ◽  
pp. 10-16
Author(s):  
SHANKHADIP NANDI
Keyword(s):  
Drug Delivery ◽  
Pharmaceutical Industry ◽  
3D Printing ◽  
Computer Aided Design ◽  
Release Kinetics ◽  
Research Work ◽  
Economic Benefits ◽  
Pharmaceutical Products ◽  
Dosage Forms ◽  
Fused Deposition

3D printing technology is a rapid prototyping process based on computer-aided design software that is proficient to construct solid objects with various geometrics by depositing numerous layers in a sequence. The major advantages of three-dimensional printing (3DP) technology over the traditional manufacturing of pharmaceuticals include the customization of medications with individually adjusted doses, on-demand tailored manufacturing, unprecedented flexibility in the design, manufacturing of complex and sophisticated solid dosage forms, and economic benefits. Recently, many researchers have been invested their efforts in applying 3DP technology to the pharmaceutical development of drug products and different drug delivery systems. Selective laser sintering, fused deposition modeling, semi-solid extrusion, stereolithography, etc., are the multiple 3DP technologies that can be established in several customized and programmable medicines. Sublingual, orodispersible, and fast-dissolving drug delivery formulations by 3DP technology have been already manufactured. Controlled-release formulations with different characteristics, doughnut-shaped multi-layered tablets with linear release kinetics, and drug-loaded tablets with modified-release characteristics are recently fabricated using 3DP. However, few 3DP methods produce uneven shapes of dosage forms and comparatively porous structures. Cost of transition, adaptation to the existing facility, achieving regulatory approval, etc., are the present challenges that can restrict the extensive application of 3DP technology to pharmaceutical products. Intense research work for modifying the 3DP methods is simultaneously sustained for by-passing the flaws and current limitations of this technology. 3DP technology can act as a convenient and potential tool for the pharmaceutical industry which will set a revolutionary manufacturing style in the near future to facilitate patient-centered health care.

scholarly journals Use of N, N-diethyl-p-phenylenediamine sulphate for the spectrophotometric determination of some phenolic and amine drugs

2010 ◽  
Vol 60 (2) ◽  
pp. 217-227 ◽  
Author(s):  
Padmarajaiah Nagaraja ◽  
Ashwinee Shrestha ◽  
Anantharaman Shivakumar ◽  
Avinash Gowda
Keyword(s):  
Spectrophotometric Determination ◽  
Correlation Coefficients ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Variable Parameters ◽  
Spectrophotometric Methods ◽  
Linear Relationships ◽  
Colored Product ◽  
And Performance

Use ofN, N-diethyl-p-phenylenediamine sulphate for the spectrophotometric determination of some phenolic and amine drugsSpectrophotometric methods are proposed for the determination of drugs containing a phenol group [salbutamol sulphate (SLB), ritodrine hydrochloride (RTD), isoxsuprine hydrochloride (IXP)] and drugs containing an aromatic amine group [dapsone hydrochloride (DAP), sulfamethoxazole (SFM), and sulfadiazine (SFD)] in pharmaceutical dosage forms. The methods are based on coupling ofN, N-diethyl-p-phenylenediamine sulphate with the drugs in the presence of KIO4to give a green colored product (λmaxat 670 nm) and a red colored product (λmaxat 550 nm), respectively. Linear relationships with good correlation coefficients (0.9986-0.9996) were found between absorbance and the corresponding concentration of drugs in the range 1-7, 2-22, 1-17, 1.5-12, 2-25, and 2-21 μg mL-1for SLB, RTD, IXP, DAP, SFM and SFD, respectively. Variable parameters such as temperature, reaction time and concentration of the reactants have been analyzed and optimized. The RSD of intra-day and inter-day studies was in the range of 0.2-1.0 and 0.4-1.0%, respectively. No interference was observed from common pharmaceutical adjuvants. The reliability and performance of the proposed methods was validated statistically; the percentage recovery ranged from 99.5 ± 0.1 to 99.9 ± 0.3%. Limits of detection were 0.14, 0.21, 0.51, 0.44, 0.33 and 0.37 μg mL-1for SLB, RTD, IXP, DAP, SFM, and SFD, respectively.

Role of the national regulatory authority for vaccines

2017 ◽  
Vol 22 (3) ◽  
pp. 128-137 ◽  
Author(s):  
Norman W. Baylor
Keyword(s):  
Regulatory Authority ◽  
Developed Countries ◽  
Pharmaceutical Products ◽  
World Health ◽  
Expert Committee ◽  
Content Type ◽  
Mortality And Morbidity ◽  
Expert Review ◽  
Regulatory Authorities ◽  
National Regulatory Authority

Purpose Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue. Design/methodology/approach Expert review. Findings Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. However, even today, many developing countries do not have established NRAs. Furthermore, despite similarities, there are still substantial differences in how regulatory authorities in different countries perform minimum functions required for effective regulation of pharmaceutical products, including vaccines. The World Health Organization (WHO), although not a governmental NRA, uses a consultative approach involving its Expert Committee on Biological Standardization and Biologicals Unit to develop regulatory criteria and identify and consolidate current consensus opinions on key regulatory issues. It is through this approach that WHO informs NRAs on the necessary scientific background required to assess and advise on optimal regulatory approaches and methodologies. This paper will focus on the evolution of the US FDA and its role in regulation of vaccines to illustrate the function of a vaccine NRA. Originality/value Vaccines are an important resource for protecting people and communities from the mortality and morbidity associated with many infectious diseases. The assessment, licensure, control and surveillance of vaccines are the responsibilities of government regulatory authorities.

scholarly journals THE EFFECT OF POLICIES OF THE RBI ON ISSUING NEW BANK LICENCES FROM POST NATIONALISATION OF BANKS IN INDIA

2021 ◽  
pp. 29-36
Author(s):  
Dr.K.Thirumamagal
Keyword(s):  
Private Sector ◽  
Central Bank ◽  
Regulatory Authority ◽  
The Other ◽  
Innovative Technology ◽  
Paper Study ◽  
Economic Stability ◽  
Regulatory Authorities ◽  
The World

In this modern scenario, Finance has become the foremost basic necessity in order to acquire the other necessities of life. The prominent financial sector are regulated by different regulatory authorities with a prime motto of protecting the interest of the customers and to uplift the weaker sections of the society. Since this strife-torn world is full of conflicts, corruption which has affected the economic stability of the state, the regulatory authorities should seriously analyze the effect of licenses going to be provided in 2014 and also it has to take in to account that the empires down the history have been known to get built only to be lost subsequently. The objective of this study is to impart the essential standards the banks of India should possess and also the challenges going to be faced by our economy due to the reckless decision of the regulatory authority. The need of this study is to safeguard the customers of us from the unscrupulous businessmen. This paper study the role of central bank and to analyze the result of providing license to the private sector, particularly the corporate houses, which is not practiced anywhere in the world. KEY WORDS: Corporates, Banks, Finance, Non Performing Asset, innovative, technology, Licenses, RBI

Factors Influencing the Design and Performance of Oral Sustained/Controlled Release Dosage Forms

2009 ◽  
Vol 2 (3) ◽  
pp. 583-594
Author(s):  
Ranjith Kumar Mamidala ◽  
Vamshi Ramana ◽  
Sandeep G ◽  
Meka Lingam ◽  
Ramesh Gannu ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Controlled Release ◽  
Oral Drug Delivery ◽  
Dosage Forms ◽  
Oral Drug ◽  
Factors Influencing ◽  
Maximum Utility ◽  
Systemic Side Effects ◽  
And Performance ◽  
Dosing Intervals

Of all drug delivery systems, oral drug delivery remains the most preferred option for administration for various drugs. Availability of wide variety of polymers and frequent dosing intervals helps the formulation scientist to develop sustained/controlled release products. Oral Sustained release (S.R) / Controlled release (C.R) products provide an advantage over conventional dosage forms by optimizing bio-pharmaceutic, pharmacokinetic and pharmacodynamic properties of drugs in such a way that it reduces dosing frequency to an extent that once daily dose is  sufficient for therapeutic management through uniform plasma concentration providing maximum utility of drug  with reduction in local and systemic side effects and cure or control condition in shortest possible time by smallest quantity of drug to assure greater patient compliance. This review describes the various factors influencing the design and performance of sustained/controlled release products along with suitable illustrations.

Modernization of the State Internal Financial Audit System of the Russian Federation

Auditor ◽  
2020 ◽  
Vol 6 (11) ◽  
pp. 31-38
Author(s):  
Larisa Pavlova
Keyword(s):  
Russian Federation ◽  
The State ◽  
Point Of View ◽  
Internal Auditor ◽  
Audit System ◽  
Regulatory Authorities ◽  
Financial Audit ◽  
The Russian Federation

Th e article examines the ongoing changes in the fi eld of internal fi nancial audit in Russia, carried out in four vectors: regulatory; personnel; empowering the internal auditor with de facto independence and improving automated systems. Th e assessment of the quality of the internal fi nancial audit system in the Russian Federation was carried out according to the data of regulatory authorities and from the point of view of the heads of fi nancial services of budgetary institutions. Measures are proposed to improve the state internal fi nancial audit.

Independent Regulatory Authorities: Analysing Accountability, Responsibility and Transparency

2018 ◽  
Vol 64 (3) ◽  
pp. 349-357
Author(s):  
Sudhanshu Tripathi
Keyword(s):  
Civil Society ◽  
Regulatory Authority ◽  
Good Governance ◽  
Provincial Government ◽  
Public Authority ◽  
Federal State ◽  
Modern State ◽  
Direct Control ◽  
Regulatory Authorities

A regulatory authority is an autonomous body established by a federal, state or provincial government with a view to serve the interests of all stakeholders in a society. As the modern state is passing through neo-liberal phase towards reforming public services for accomplishing its goals for good governance, the role of Independent Regulatory Authorities becomes very important. But the spread of independent regulators means that more and more aspects of our lives are shaped by decisions made by institutions that are neither popularly elected nor are they under direct control of elected officials. Obviously, this has important implications for their accountability, responsibility and transparency in the present age of expanding democracy. A way-out may be to re-theorise public authority as an office for coordinating and harmonising diverse interests in a professional way so as to suit the requirements of governance conjointly performed by the state, civil society and market.

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