scholarly journals Antimicrobial testing of healthcare and industrial products

2010 ◽  
Vol 31 (4) ◽  
pp. 185
Author(s):  
Oaul Priscott
Keyword(s):  
New Products ◽  
Development Work ◽  
Testing Methods ◽  
Regulatory Requirements ◽  
Industrial Testing ◽  
Product Categories ◽  
Regulatory Guidelines ◽  
Scientific Principles ◽  
Standardised Testing ◽  
Test Result

For the industrial microbiologist the testing landscape comprises a plethora of standardised testing methods. Often these are to be followed rigorously according to regulatory guidelines or rules. Sometimes the product or application may require some modification of a standard method to achieve a more realistic test result. Very occasionally, a method must be developed from scratch, based upon scientific principles and, where possible, utilising approaches used in either published papers or standards. Industrial testing is usually undertaken for one of two reasons, namely development work for new products or to satisfy regulatory requirements in order to market the product. This discussion will emphasise healthcare products, other than antibiotics, but similar principles will apply to other product categories also, albeit often to a lesser degree of testing.

Specific features of designing and testing interchangeable bodies

2020 ◽  
Vol 17 (4) ◽  
pp. 465-476
Author(s):  
G. O. Panov ◽  
◽  
S. M. Tolstov ◽  
L. V. Tsyganskaia ◽  
I. O. Morozova ◽  
...  
Keyword(s):  
Bearing Capacity ◽  
Practical Importance ◽  
Regulatory Framework ◽  
Development Work ◽  
Technical Standard ◽  
Testing Methods ◽  
Regulatory Requirements ◽  
The Difference ◽  
Conducting Research ◽  
Standard Documents

Objective: Defi nition and systematisation of loads occurring during operation of interchangeable wagon bodies for development of corresponding regulatory requirements for designing and testing interchangeable bodies. Methods: Loads and methods of their application are determined as a result of comparison of design and application area of interchangeable bodies with cargo (maritime) containers and demountable bodies. Results: The authors identifi ed a lack of regulatory framework for standardisation of requirements for bearing capacity of interchangeable bodies, for loads that occur in the railway sphere of application, including storage, handling and stockpiling, as well as testing methods for these bodies. The difference between interchangeable and demountable bodies is defi ned as lack of need for transportation of interchangeable bodies by waterborne transport. In the process of consideration of specifi c features of operating interchangeable bodies in the railway sphere of application, including storage, handling and stockpiling, design and operational similarity of interchangeable bodies with cargo (maritime) containers and demountable bodies was established. Loads applied to interchangeable bodies were defi ned and systemised. Practical importance: The need for development of a regulatory framework for standardisation of requirements for bearing capacity of interchangeable bodies and for loads that occur during handling and stockpiling operations. The authors recommend that the loads discussed in the paper be taken into account in development of technical standard documents, in conducting research and development work and in testing interchangeable bodies

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

2020 ◽  
Vol 7 (3) ◽  
pp. 162-176
Author(s):  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
Vikas Rathee
Keyword(s):  
Regulatory Requirements ◽  
Health Value ◽  
Drug Products ◽  
Registration Process ◽  
Potential Market ◽  
Regulatory Guidelines ◽  
Cis Countries ◽  
In Cis ◽  
Regulatory Organization ◽  
Country Specific

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

Comparison of Regulatory Requirements for Pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia

2020 ◽  
Vol 7 (1) ◽  
pp. 37-44
Author(s):  
Shivani Jani ◽  
Nilesh Patel ◽  
Urvi Chotaliya ◽  
Ashok Patel
Keyword(s):  
European Union ◽  
Union Member ◽  
Regulatory Requirements ◽  
Member States ◽  
Registration Process ◽  
Eu Membership ◽  
Regulatory Guidelines ◽  
Small Countries ◽  
European Union Member States ◽  
The Eu

Background: Literature review suggested that regulatory guidelines should be harmonized for better processing of applications and for the upliftment of the regulatory field. Therefore it was thought worthwhile to compare the guidelines for countries where there is requirement of harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries and still they are not a part of EU. Introduction: Kosovo, Ukraine and Serbia are small countries of Europe but they are not members of European Union. They have their own guidelines for the submission of MAA for marketing of pharmaceuticals and medical devices. They are trying to obtain the EU membership and therefore it was worthwhile to compare the guidelines of these countries. Method: The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied throughly. Along with it, the guidelines for European Union were also studied. A comparison of guidelines of all the three countries with the guidelines of European Union for pharmaceuticals was carried out. Result: The comparison of guidelines showed that there are still some changes needed in the guidelines of Kosovo, Ukraine and Serbia before they can merge with the guidelines of European Union. Some of the points in the guidelines are very different from the guidelines of EU. Conclusion: So it was worthwile to study the regulatory requirements of pharmaceuticals in Non- European Union Member States Kosovo, Ukraine and Serbia.

Governmental perspectives on evaluating laboratory performance

1993 ◽  
Vol 39 (7) ◽  
pp. 1461-1467 ◽  
Author(s):  
D J Boone
Keyword(s):  
Medical Decision Making ◽  
Medical Decision ◽  
Diagnostic Efficiency ◽  
Regulatory Requirements ◽  
Misleading Information ◽  
Potential Patient ◽  
Precision And Accuracy ◽  
Total Testing Process ◽  
Test Result

Abstract The quality of laboratory analytical performance required to support medical decision-making has been defined in four major ways: (a) by the analytical variance of the state of the practice; (b) by the total variance, including analytical and biological variability; (c) by the loss of diagnostic efficiency attributable to analytical error; and (d) by medical-usefulness criteria. From the federal government's perspective, the answer to the question "How good must a laboratory test result be to be medically relevant?" must take into account the clinical context of the test, with accompanying concerns about access, timeliness, and cost, as well as limits for precision and accuracy in the analytical process and the frequency and potential patient-care impact of error in the pre- and postanalytical steps of the total testing process. Therefore, medically relevant goals should encompass not only analytical precision and accuracy but also goals to provide access to clinically effective tests and to reduce errors in the total testing process that can lead to medically misleading information. Development of more appropriate regulatory requirements for laboratories, as well as any needed improvements in instrumentation and methodology, should focus on ensuring that goals for medically relevant results are met by appropriate design and management of the entire process of laboratory testing.

scholarly journals Toxicity testing is evolving!

2020 ◽  
Vol 9 (2) ◽  
pp. 67-80 ◽  
Author(s):  
Ida Fischer ◽  
Catherine Milton ◽  
Heather Wallace
Keyword(s):  
Systematic Approach ◽  
Toxicity Testing ◽  
Testing Methods ◽  
Regulatory Requirements ◽  
New Approach ◽  
Chemical Substances ◽  
Experimental Animals ◽  
The Public ◽  
Efficient Management ◽  
Regulatory Decisions

Abstract The efficient management of the continuously increasing number of chemical substances used in today’s society is assuming greater importance than ever before. Toxicity testing plays a key role in the regulatory decisions of agencies and governments that aim to protect the public and the environment from the potentially harmful or adverse effects of these multitudinous chemicals. Therefore, there is a critical need for reliable toxicity-testing methods to identify, assess and interpret the hazardous properties of any substance. Traditionally, toxicity-testing approaches have been based on studies in experimental animals. However, in the last 20 years, there has been increasing concern regarding the sustainability of these methodologies. This has created a real need for the development of new approach methodologies (NAMs) that satisfy the regulatory requirements and are acceptable and affordable to society. Numerous initiatives have been launched worldwide in attempts to address this critical need. However, although the science to support this is now available, the legislation and the pace of NAMs acceptance is lagging behind. This review will consider some of the various initiatives in Europe to identify NAMs to replace or refine the current toxicity-testing methods for pharmaceuticals. This paper also presents a novel systematic approach to support the desired toxicity-testing methodologies that the 21st century deserves.

scholarly journals Regulatory aspects for Biologic Product licensing in Australia

2019 ◽  
Vol 7 (2) ◽  
pp. 1-6
Author(s):  
Sanjeev Kumar Maurya ◽  
Vikesh Kumar Shukla ◽  
Sunny Kumar Maurya ◽  
Prachi Kaushik
Keyword(s):  
Human Cells ◽  
Human Tissues ◽  
Animal Cells ◽  
Regulatory Requirements ◽  
Live Animal ◽  
Regulatory Aspects ◽  
Physiological Processes ◽  
Market Authorization ◽  
Regulatory Guidelines ◽  
Biologic Product

The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person. The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will: Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1). Explains the Australian regulatory requirements for supplying of Biologicals Explains what is required for the market authorization as per TGA especially for Biologicals.

Changes in India’s Import Basket: An Exploratory Analysis of the U.S. Export Data

2014 ◽  
Vol 10 (4) ◽  
pp. 247-264
Author(s):  
Soumendra Nath Banerjee ◽  
Boishampayan Chatterjee
Keyword(s):  
New Products ◽  
Exploratory Analysis ◽  
Product Diversification ◽  
Product Categories ◽  
Export Sector ◽  
Skill Intensity ◽  
The U.S

This paper attempts to understand India’s import growth from the U.S. between 1991 and 2006. In particular, we analyse how the allocation of industries in the export sector, skill intensity of products, product diversification, and contributions of new products have changed as India’s imports from the U.S. have grown. Our findings suggest that India’s import from the U.S. in 2006 has increased in the more sophisticated product categories. Furthermore, our study finds that India has diversified in the range of products it is importing from the U.S., with new products gaining an increased share in India’s import basket.

Designing dementia treatment studies: Diagnosis, efficacy criteria, and duration

1996 ◽  
Vol 11 (3) ◽  
pp. 149-154 ◽  
Author(s):  
R Spiegel ◽  
P Irwin
Keyword(s):  
United States ◽  
Return On Investment ◽  
The United States ◽  
Regulatory Requirements ◽  
Regulatory Guidelines ◽  
Efficacy Criteria ◽  
Feasible Study ◽  
Long Term Studies ◽  
Symptomatic Benefit

SummaryDevelopment of treatments for dementia is beset by special problems in defining the diagnosis, establishing efficacy criteria, and specifying the necessary duration of study. There is need for agreement among clinicians and scientists on diagnostic subgroups of dementia. Similarly, there is a need for harmonization of the regulatory guidelines in Europe, Japan, and the United States regarding the decision set of variables on which to base efficacy claims. The duration of trials must be based upon the intended claim: transient symptomatic benefit, maintained symptomatic benefit, or a therapeutic effect on disease progression. Claims other than transient benefit require long-term trials, suggested to be of at least six months in duration. Problems with long-term studies include slow patient accrual, high dropout rates, changing milieu, low return on investment, and lack of unanimity regarding regulatory requirements. Regulatory authorities must come to some accord, consonant with current clinical/scientific wisdom and consensus, regarding diagnosis, efficacy criteria, and feasible study duration, in order to attract continued sponsor investment in the development of antidementia treatments.

scholarly journals Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health

J ◽  
2021 ◽  
Vol 4 (2) ◽  
pp. 206-222
Author(s):  
Marc Holfelder ◽  
Lena Mulansky ◽  
Winfried Schlee ◽  
Harald Baumeister ◽  
Johannes Schobel ◽  
...  
Keyword(s):  
Medical Device ◽  
Development Process ◽  
Regulatory Requirements ◽  
Healthcare Environment ◽  
Medical App ◽  
Regulatory Guidelines ◽  
Enormous Amount ◽  
Software Engineers ◽  
Mhealth Apps ◽  
Medical Device Regulation

Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the COVID-19 pandemic has led to an enormous amount of app releases. In most countries, mHealth applications have to be compliant with several regulatory aspects to be declared a “medical app”. However, the latest applicable medical device regulation (MDR) does not provide more details on the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team—especially software engineers—are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled due to integration of the MDR. Therefore, a developing framework that includes these aspects is required to facilitate a reliable and quick development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized as a guidance for medical app developments during the pandemic and beyond. In particular, the important stages and challenges faced that emerged during the entire development process are highlighted.

scholarly journals Overview of the testing and assessment of effects of microbial pesticides on bees: strengths, challenges and perspectives

Apidologie ◽  
2021 ◽  
Author(s):  
Shannon Borges ◽  
Abdulrahim T. Alkassab ◽  
Elizabeth Collison ◽  
Silvia Hinarejos ◽  
Ben Jones ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Apis Mellifera ◽  
Honey Bees ◽  
Lower Risk ◽  
Plant Protection ◽  
Risk Profile ◽  
Testing Methods ◽  
Regulatory Requirements ◽  
Microbial Pesticides ◽  
Chemical Pesticides

AbstractCurrently, there is a growing interest in developing biopesticides and increasing their share in the plant protection market as sustainable tools in integrated pest management (IPM). Therefore, it is important that regulatory requirements are consistent and thorough in consideration of biopesticides’ unique properties. While microbial pesticides generally have a lower risk profile, they present special challenges in non-target organism testing and risk assessment since, in contrast to chemical pesticides, their modes of action include infectivity and pathogenicity rather than toxicity alone. For this reason, non-target organism testing guidelines designed for conventional chemical pesticides are not necessarily directly applicable to microbial pesticides. Many stakeholders have recognised the need for improvements in the guidance available for testing microbial pesticides with honey bees, particularly given the increasing interest in development and registration of microbial pesticides and concerns over risks to pollinators. This paper provides an overview of the challenges with testing and assessment of the effects of microbial pesticides on honey bees (Apis mellifera), which have served as a surrogate for both Apis and non-Apis bees, and provides a foundation toward developing improved testing methods.

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