scholarly journals Rotulagem de medicamentos industrializados: uma análise das diretrizes legais brasileiras e contribuições para a qualidade de produtos

2020 ◽  
Vol 20 (81) ◽  
Author(s):  
Márcia Lombardo
Keyword(s):  
Drug Product ◽  
Regulatory Agencies ◽  
Quality And Safety ◽  
Sources Of Information ◽  
Normative Documents ◽  
Drug Products ◽  
Legal Provisions ◽  
Product Surveillance ◽  
Study Results ◽  
Regulatory Knowledge

RESUMOObjetivos: a rotulagem é um aspecto de qualidade fundamental no uso de medicamentos, seja pelo profissional de saúde, seja pelo paciente. Este trabalho propôs uma análise crítica do tema com base na legislação em vigor, bem como a triagem de documentos normativos úteis no processo de elaboração ou de avaliação da conformidade da rotulagem de medicamentos. Métodos: foi realizada uma pesquisa documental empregando-se como fonte de informações os sítios eletrônicos oficiais do Ministério da Saúde e da Agência Nacional de Vigilância Sanitária. Os documentos contendo itens pertinentes a rotulagem de medicamentos e classificados como vigentes ou vigentes com alteração foram selecionados para a realização do estudo. Resultados: os quesitos mais relevantes das disposições gerais e das disposições específicas da norma vigente para rotulagem de medicamentos foram sistematizados, verificando-se suas contribuições na qualidade e segurança de produtos. Embora a padronização da rotulagem de medicamentos seja necessária, a ocorrência de elevados graus de semelhança entre rótulos, embalagens ou mesmo nomenclaturas é discutida no âmbito da prática clínica e esta questão merece atenção especial. A busca de material complementar à legislação vigente resultou no levantamento de um total de 20 documentos, incluindo normas, guias, bancos de consulta e planilhas, que podem auxiliar no cumprimento dos requisitos de rotulagem de medicamentos. Conclusão: rótulos de medicamentos são recursos técnicos que contribuem na eficácia e na segurança do tratamento. Os esforços das Agências Reguladoras têm permitido a consolidação de diretrizes legais para que informações e formatos adequados de rotulagem sejam aplicados nas embalagens de medicamentos industrializados. A elaboração ou a análise da rotulagem de medicamentos requer amplo conhecimento regulatório, o qual é dinâmico e, portanto, um grande desafio.Palavras-chave: Rotulagem de Medicamentos. Legislação de Medicamentos. Vigilância de Produtos Comercializados. Segurança do Paciente. ABSTRACTObjectives: the labeling of drug products is an aspect of quality that is fundamental to the use of medicines, whether by the health professional or by the patient. This work proposed a critical analysis of the current legislation on the labeling of drug products, as well as the screening of normative documents useful for the process of preparing or assessing the conformity of labels. Methods: a documentary research was carried out using the official websites of the Ministry of Health and the National Health Surveillance Agency (Brazil) as sources of information. The documents containing relevant items on labeling of drug products and classified as current or current with changes were selected for the study. Results: the most important requirements of the general and specific provisions from the current legislation have been systematized, and their contributions to the quality and safety of products have been verified. Although the standardization of the labeling is necessary, the occurrence of high degrees of similarity between labels, packaging or even nomenclatures is discussed in the context of clinical practice and this issue deserves special attention. The search for material complementary to the current legislation resulted in the collection of a total of 20 documents, including normative documents, guides, databases and spreadsheets, which might help in complying with the requirements for the labeling of drug products. Conclusion: the labeling of drug products are technical resources that contribute to the effectiveness and safety of treatment. The efforts of the Regulatory Agencies have allowed the consolidation of legal provisions for the dissemination of appropriate information and labeling formats in the packaging of drug products. The drafting or analysis of the labels requires extensive regulatory knowledge, which is dynamic and, therefore, a great challenge.Keywords: Drug Labeling. Legislation, Drug. Product Surveillance, Postmarketing. Patient Safety.

A review and analysis of product recall for pharmaceutical drug product

2021 ◽  
pp. 174113432110338
Author(s):  
Ashish Miglani ◽  
Chandan Saini ◽  
Pankaj Musyuni ◽  
Geeta Aggarwal
Keyword(s):  
Drug Product ◽  
Pharmaceutical Product ◽  
Regulatory Agencies ◽  
Primary Concern ◽  
Product Recalls ◽  
Product Recall ◽  
High Quality ◽  
Pharmaceutical Drug ◽  
Drug Products ◽  
Digital World

The pharmaceutical industry's primary concern is to provide high-quality drug products to the general public, so drug recalls play an important role in maintaining the quality system by removing defective products from the market. Pharmaceutical product recalls are increasing at an alarming rate as a result of increased inspection rates and the introduction of modernization and the digital world into the industry, raising concerns for regulatory agencies and public health to focus on more stringent regulations to control future recalls of defective drug products. This article will provide an overview of recall procedures, their impact on the pharmaceutical industry, and the various steps taken to reduce pharmaceutical recalls.

Pollution Control – Regulation and Legal Provisions in India

1988 ◽  
Vol 20 (10) ◽  
pp. 57-62
Author(s):  
A. N. Aggarwal ◽  
V. K. Karia
Keyword(s):  
Environmental Protection ◽  
State Government ◽  
Pollution Control ◽  
Regulatory Agencies ◽  
Legal Provisions ◽  
Fiscal Incentives ◽  
Control Regulation ◽  
Regulatory Approach ◽  
Tax Benefits ◽  
The Government

Immediately after independence in 1946, the Government of India resorted to rapid industrialization to minimize outside dependence and to improve the standard of living. This, while helping the country to grow, also created problems of environmental management. Rapid deterioration of natural resources forced the Government to enact a number of legislative measures and create regulatory agencies both at central and state government levels. These agencies were given powers to effectively implement various Acts. Severe penalties, including fines and imprisonment, were envisaged for offenders of environmental Acts. Responsibilities were defined, to avoid a scapegoat approach. On the other hand, to reward industries showing a positive approach to environmental protection, a number of fiscal incentives and tax benefits were also offered. Recently, to provide more comprehensive legislation for the protection of all the components of the environment under a single agency, a new bill entitled the ‘Environmental Protection Bill, 1986' has been introduced in Parliament. This regulatory approach has started to show results, and more and more industries have started to provide pollution control facilities.

3D Printing in Pharmaceuticals: Regulatory Perspective

2019 ◽  
Vol 24 (42) ◽  
pp. 5081-5083 ◽  
Author(s):  
Mohd. A. Mirza ◽  
Zeenat Iqbal
Keyword(s):  
New Technologies ◽  
Pharmaceutical Product ◽  
Regulatory Agencies ◽  
Major Research ◽  
Data Bases ◽  
Drug Products ◽  
Regulatory Perspective ◽  
Regulatory Guidelines ◽  
Recent Developments ◽  
Technical Issues

Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”. Methods: Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google Scholar were also ferreted for any relevant repository of publications are referred to wherever required. Results: So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to the academic domain. Conclusion: It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in foolproof regulatory guidelines which would ultimately lead to the success of this revolutionary technology.

scholarly journals Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1051
Author(s):  
Jonattan Gallegos-Catalán ◽  
Zachary Warnken ◽  
Tania F. Bahamondez-Canas ◽  
Daniel Moraga-Espinoza
Keyword(s):  
New Technologies ◽  
Innovation Process ◽  
Cost Effective ◽  
Regulatory Agencies ◽  
Drug Products ◽  
Effective Strategies ◽  
Rate Analysis ◽  
Orally Inhaled Drug Products ◽  
Next Generation Impactor ◽  
First Time

Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat pulmonary diseases. Over the past decade, this trend has broadened, increasing their use in other conditions such as diabetes, expanding the interest in this administration route. Thus, the bioequivalence of OIDPs is more important than ever, aiming to increase access to affordable, safe and effective medicines, which translates into better public health policies. However, regulatory agencies leading the bioequivalence process are still deciding the best approach for ensuring a proposed inhalable product is bioequivalent. This lack of agreement translates into less cost-effective strategies to determine bioequivalence, discouraging innovation in this field. The Next-Generation Impactor (NGI) is an example of the slow pace at which the inhalation field evolves. The NGI was officially implemented in 2003, being the last equipment innovation for OIDP characterization. Even though it was a breakthrough in the field, it did not solve other deficiencies of the BE process such as dissolution rate analysis on physiologically relevant conditions, being the last attempt of transferring technology into the field. This review aims to reveal the steps required for innovation in the regulations defining the bioequivalence of OIDPs, elucidating the pitfalls of implementing new technologies in the current standards. To do so, we collected the opinion of experts from the literature to explain these trends, showing, for the first time, the stakeholders of the OIDP market. This review analyzes the stakeholders involved in the development, improvement and implementation of methodologies that can help assess bioequivalence between OIDPs. Additionally, it presents a list of methods potentially useful to overcome some of the current limitations of the bioequivalence standard methodologies. Finally, we review one of the most revolutionary approaches, the inhaled Biopharmaceutical Classification System (IBCs), which can help establish priorities and order in both the innovation process and in regulations for OIDPs.

scholarly journals Current hurdles to the translation of nanomedicines from bench to the clinic

2021 ◽  
Author(s):  
Snežana Đorđević ◽  
María Medel Gonzalez ◽  
Inmaculada Conejos-Sánchez ◽  
Barbara Carreira ◽  
Sabina Pozzi ◽  
...  
Keyword(s):  
Drug Product ◽  
Early Stage ◽  
Regulatory Agencies ◽  
Important Process ◽  
Close Collaboration ◽  
Critical Quality Attributes ◽  
Research Areas ◽  
Physical Chemical ◽  
Clinical Models ◽  
Further Development

AbstractThe field of nanomedicine has significantly influenced research areas such as drug delivery, diagnostics, theranostics, and regenerative medicine; however, the further development of this field will face significant challenges at the regulatory level if related guidance remains unclear and unconsolidated. This review describes those features and pathways crucial to the clinical translation of nanomedicine and highlights considerations for early-stage product development. These include identifying those critical quality attributes of the drug product essential for activity and safety, appropriate analytical methods (physical, chemical, biological) for characterization, important process parameters, and adequate pre-clinical models. Additional concerns include the evaluation of batch-to-batch consistency and considerations regarding scaling up that will ensure a successful reproducible manufacturing process. Furthermore, we advise close collaboration with regulatory agencies from the early stages of development to assure an aligned position to accelerate the development of future nanomedicines. Graphical abstract

scholarly journals Nursing students’ perception of safety in clinical settings: From the quality and safety officer

2017 ◽  
Vol 7 (10) ◽  
pp. 91 ◽  
Author(s):  
Elizabeth E. Cooper
Keyword(s):  
Nursing Students ◽  
Nursing Student ◽  
Near Miss ◽  
Clinical Settings ◽  
Primary Concern ◽  
Quality And Safety ◽  
Safety Issues ◽  
Perception Of Safety ◽  
Study Results ◽  
Safety Officer

Teaching methods to improve the safety of care for patients has been a priority for nurse educators. This article discusses the student nurses’ use of error reporting tools in the clinical setting, revealing study results completed by the Quality and Safety Officer in a School of Nursing and Health Professions. The aim was to report on the use of safety tools and the perception of safety issues in clinical settings identified by 121 prelicensure baccalaureate nursing students. Responses suggest that it is challenging for nursing students to report errors and near miss events. Barriers exist for the nursing student. The survey reveals difficulty in reporting but discloses that safety for the patient continues to be a primary concern for the nursing student.

scholarly journals Container Closure and Delivery Considerations for Intravitreal Drug Administration

2021 ◽  
Vol 22 (3) ◽  
Author(s):  
Ashwin C. Parenky ◽  
Saurabh Wadhwa ◽  
Hunter H. Chen ◽  
Amardeep S. Bhalla ◽  
Kenneth S. Graham ◽  
...  
Keyword(s):  
Adverse Events ◽  
Product Development ◽  
Drug Product ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Volume Determination ◽  
Common Procedure ◽  
Drug Products ◽  
Fill Volume ◽  
Container Closure

AbstractIntravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.

scholarly journals Adolescents' Health Literacy and Decision-making: A Qualitative Study

2020 ◽  
Vol 44 (4) ◽  
pp. 392-408
Author(s):  
Sasha A. Fleary ◽  
Patrece Joseph
Keyword(s):  
Decision Making ◽  
Health Literacy ◽  
Future Orientation ◽  
Subjective Health ◽  
Lifestyle Behaviors ◽  
Sources Of Information ◽  
Multiple Sources ◽  
Health Decision Making ◽  
Study Results ◽  
Health Decision

Objective: Adolescents assume increased responsibility for their health, particularly regarding health decision-making for lifestyle behaviors. Prior research suggests a relationship between health literacy (HL) and health behaviors in adolescents. Yet, the specific role of HL in adolescents' health decision-making is unclear. This study qualitatively explored adolescents' use of HL in their health decision-making. Methods: Six focus groups with adolescents (N = 37, Mage = 16.49, 86% girls) were conducted. Adolescents' responses to questions about their HL use were coded using thematic analysis. Results: Adolescents identified passive and active HL engagement and several individual (eg, future orientation, risk perception) and environmental (eg, access to resources/information, media) factors that influenced their use of HL in health decision-making. Feedback from others, subjective health, and ability to navigate multiple sources of information also determined adolescents' confidence in their HL skills. Conclusions: Our results support expanding the types of HL studied/measured in adolescents and provide insight on how HL can be leveraged to improve adolescents' health decision-making. Though there was no guiding theory for this study, results support using the Information-Motivation-Behavior Skills model to assess the HL/health decision-making relationship in adolescence.

scholarly journals Rapid microbiological testing method

2020 ◽  
Vol 11 (3) ◽  
pp. 3927-3932
Author(s):  
Raghuprakash P ◽  
Gowrav M P ◽  
Gangadharappa H V ◽  
Hemanth Kumar S
Keyword(s):  
Clinical Laboratory ◽  
Drug Product ◽  
Free Products ◽  
Hygienic Condition ◽  
Cycle Times ◽  
Drug Products ◽  
Microbiological Methods ◽  
Wide Range ◽  
Microbiological Testing ◽  
Microorganism Identification

Classical microbiological methods currently have unacceptably long cycle times. Rapid microbiological strategies are accessible within the marketplace for about 10 years and are mostly used in the clinical laboratory and in food industries. However, their reapplication in the pharma industry has wide range of advantage. A comparison with ancient strategies to be conjointly performed. During this review, data concerning the validation of RMM strategies described within the document was given in addition as proof of the issue of validation of those strategies. A comparison with ancient strategies is additionally mentioned. This data is beneficial to the industries and in the labs which will doubtless be adopted. These strategies for microorganism free products. This methodology for microorganism identification will be delicate, accurate and fast. How the laboratory should be maintained for carrying out different tests, there should be good hygienic condition maintained. This article also includes different methods for identifying bacteria which is present in drug products as well as the material which are used for doing test. Presence of bacteria may affect the activity of drug product and bio availability may decreases and potency the drug may loss. How the laboratory should be maintained for carrying out different tests, there should be good hygienic condition maintained.

scholarly journals Liposome Characterization, Applications and Regulatory landscape in US

2021 ◽  
Vol 9 (2) ◽  
pp. 81-89
Author(s):  
Amit Kumar ◽  
Madhu Gupta ◽  
Simran Braya
Keyword(s):  
Drug Product ◽  
Drug Carrier ◽  
Current Status ◽  
Liposomal Drug ◽  
Drug Products ◽  
Target Drug Delivery ◽  
Target Drug ◽  
Conventional Drug ◽  
Regulatory Guidelines ◽  
Reduced Toxicity

Liposomes are lipid based drug carrier whose therapeutic performance depends on their structure. Liposomes offer several advantages over the conventional drug like target drug delivery, reduced toxicity, and extended pharmacokinetics. Characterization and Identification of critical attribute of liposomal formulation and suitable strategies for control during product development is important for quality of the liposomal drug product. This paper discusses the current status of the liposomal drug product and strategy used in regulating liposome product. Despite of lack of regulatory guidelines many liposome formulations get approved which shows the potential of liposome drug products.

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