scholarly journals Significance of Personnel Hygiene Practices in Pharmaceutical Industry

2021 ◽  
Vol 9 (4) ◽  
pp. 1-5
Author(s):  
Anuradha Shenvi ◽  
Krishnananda Kamath K ◽  
E.V.S. Subrahmanyam ◽  
A R Shabaraya
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Product ◽  
Pharmaceutical Products ◽  
Vital Role ◽  
Hygiene Practices ◽  
Policies And Procedures ◽  
Hygiene Factors ◽  
Safe Product ◽  
Safe Working Condition

Personnel hygiene is very important in the pharmaceutical industry to prevent or reduce any kind of contamination which can affect the quality of medicinal products. When it comes to delivering highest quality standards of pharmaceutical products, key hygiene factors must to be upheld. Good personnel hygiene policies and practices are the foundation for successful product safety and purity. They are the backbone of a meaningful Good manufacturing Practices (GMP). Proper personnel training and sanitation are of prime importance. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. All personnel should undergo medical check-up which may be a prerequisite for safe working condition. Personnel hygiene policies and procedures are to be followed by all personnel including management, visitors, production, sanitation and maintenance staff, for reducing the chance of product contamination. Personnel hygiene practices and procedures play a vital role in pharmaceutical industry in order to achieve a good quality and safe product.

scholarly journals Blockchain Technology Factor for Improve Good Distribution Practice in the Pharmaceutical Industry

2020 ◽  
Vol 8 (6) ◽  
pp. 2174-2180
Keyword(s):  
Pharmaceutical Industry ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Drug Distribution ◽  
Pharmaceutical Products ◽  
Related Literature ◽  
Blockchain Technology ◽  
Distribution Process ◽  
The Many

The distribution process is one of the processes that occur in all industries, including the pharmaceutical industry. The distribution of medicines in the pharmaceutical industry is the most important to provide quality pharmaceutical products to patients or consumers. With several problems that occur in the distribution of drugs in things that currently should be considered. This happens a lot due to the many drugs that disagree with the provisions or such illegal or false drugs. This research investigates the use of blockchain technology for drug distribution in Indonesia. This research uses a systematic literature review method with related literature. The results of this research found 54 blockchain factors that were used to improve nine aspects of good distribution practices and to ensure the good quality of medicines distributed to consumers

scholarly journals History and Background of the Implementation of Good Manufacturing Practice Standards in the Pharmaceutical Industry (Review)

2020 ◽  
Vol 6 (9) ◽  
pp. 182-191
Author(s):  
N. Toktonalieva ◽  
I. Toktonaliev
Keyword(s):  
Pharmaceutical Industry ◽  
Scientific Literature ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Pharmaceutical Market ◽  
High Quality ◽  
Practice Standards ◽  
International Good

The volume of the global pharmaceutical market in 2018 amounted to 1.2 trillion US dollars, and by 2020 the global pharmaceutical market has grown to 1.5 trillion dollars. Countries such as the United States, Japan, Germany, Switzerland and Great Britain took the leading positions in the pharmaceutical market, while the market share of the member states of the Eurasian Economic Union (EAEU) in the world community was 2.6%. Further growth of the global pharmaceutical market is predicted by 5% annually, which may contribute to the rapid production and distribution of low-quality pharmaceutical products. One of the main goals of the country is to provide the population with effective, high-quality and safe medicines drugs to protect their health, since consumers cannot assess the quality of medicines on their own. To accomplish this task in developed and developing countries, the state regularly checks and evaluates the quality, efficacy, safety, as well as the main pharmacological effects of drugs at all stages of production. In the production of drugs, it is necessary to comply with the rules of Good Manufacturing Practice. Good Manufacturing Practice is one of the indispensable elements of a modern control and authorization system in the field of pharmaceutical circulation, no less important than the Pharmacopoeia or other state drug standards. Materials and methods. The review article presents an analysis of published scientific works of the last 15 years. To search for reliable information, we used scientific literature data from available and open sources placed in scientific electronic databases: Cyberleninka, PubMed, E-library, Medline, J-stage, Hindawi using the keywords: Good Manufacturing Practice, GMP, pharmaceutical industry, quality of medicines. Results. When analyzing scientific literature sources, special attention is paid to the relevance of this problem, the prerequisites for the introduction of Good Manufacturing Practice standards in the pharmaceutical industry and world practice. Conclusion. Summarizing the scientific literature data, we came to the conclusion that it is necessary to comply with the basic requirements of the international Good Manufacturing Practice standard for the production of high-quality drugs, which has a positive effect on the health of consumers.

scholarly journals Model-Based Scale-up Methodologies for Pharmaceutical Granulation

Pharmaceutics ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 453
Author(s):  
Eun Ha Jang ◽  
Yun Sang Park ◽  
Min-Soo Kim ◽  
Du Hyung Choi
Keyword(s):  
Pharmaceutical Industry ◽  
Process Parameters ◽  
Drug Product ◽  
Scale Up ◽  
Quality Attributes ◽  
Modeling Method ◽  
Drug Products ◽  
Model Based ◽  
Process Strategy

In the pharmaceutical industry, it is a major challenge to maintain consistent quality of drug products when the batch scale of a process is changed from a laboratory scale to a pilot or commercial scale. Generally, a pharmaceutical manufacturing process involves various unit operations, such as blending, granulation, milling, tableting and coating and the process parameters of a unit operation have significant effects on the quality of the drug product. Depending on the change in batch scale, various process parameters should be strategically controlled to ensure consistent quality attributes of a drug product. In particular, the granulation may be significantly influenced by scale variation as a result of changes in various process parameters and equipment geometry. In this study, model-based scale-up methodologies for pharmaceutical granulation are presented, along with data from various related reports. The first is an engineering-based modeling method that uses dimensionless numbers based on process similarity. The second is a process analytical technology-based modeling method that maintains the desired quality attributes through flexible adjustment of process parameters by monitoring the quality attributes of process products in real time. The third is a physics-based modeling method that involves a process simulation that understands and predicts drug quality through calculation of the behavior of the process using physics related to the process. The applications of these three scale-up methods are summarized according to granulation mechanisms, such as wet granulation and dry granulation. This review shows that these model-based scale-up methodologies provide a systematic process strategy that can ensure the quality of drug products in the pharmaceutical industry.

OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION

2013 ◽  
Vol 1 (1) ◽  
pp. 1-4
Author(s):  
Jitendra Kumar Badjatya
Keyword(s):  
Quality Of Life ◽  
Pharmaceutical Industry ◽  
Medical Devices ◽  
Legal Aspects ◽  
Pharmaceutical Products ◽  
Regulatory Agencies ◽  
Regulatory Requirements ◽  
Pharmaceutical Drug ◽  
Regulatory Affairs

Pharmaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a broad spectrumcovering all aspects of documentation and marketing in legalized form. The pharmaceutical industry is highly regulatedindustries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceuticalindustries and worldwide regulatory agencies. Regulatory Affairs (RA), is a profession within synchronized variousindustries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a veryspecific meaning within the pharmaceutical industries.DRA is a dynamic, rewarding field that includes both scientific and legal aspects of drug development. DRA professionalsare dedicated individuals who take pride in their contribution to improving the health and quality of life of peoples.RA as profession is broader than registration of products, they advise companies both strategically and technically at thehighest level. Their role begins right from development of a product to making, marketing and post marketing.Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientificthinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are alsoplaced upon the claims which can be made for the product on labeling or in advertising.

The Effect of Cleanroom Design and Manufacturing Systems on the Microbiological Contamination of Aseptically Filled Products

1985 ◽  
Vol 28 (3) ◽  
pp. 25-27
Author(s):  
William Frieben
Keyword(s):  
Pharmaceutical Industry ◽  
Manufacturing Systems ◽  
Cost Effective ◽  
Pharmaceutical Products ◽  
Microbiological Contamination ◽  
Small Particles ◽  
Manufactured Products ◽  
Design And Manufacturing ◽  
Microelectronics Industry

Although cleanroom technology is employed in both the microelectronics and the pharmaceutical industry, the objectives of the two industries are different. The microelectronics industry is concerned about very small particles (i.e. < 0.3μm) in the manufacturing environment and often spends large amounts of money to control pariculate matter in the environment. The pharmaceutical industry, on the other hand, directs its efforts toward minimizing the risk of microbiological contamination. While the cleanroom extremes employed by the microelectronics industry certainly would not harm the quality of pharmaceutical products, they may not be the most cost-effective methods to minimize microbiological contamination. This paper explores various types of manufacturing constraints that can be employed to improve the sterility assurance of aseptically manufactured products.

Problems Facing the Arab Pharmaceutical Industry: A Case Study from Yemen

2016 ◽  
Vol 2 (4) ◽  
pp. 234-241
Author(s):  
Mohammed Al-Shakka ◽  
Ebtesam Abood ◽  
Adel Al-Dhubhany ◽  
Sami Abdo Radman Aldubai ◽  
Khaled Said ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Low Income ◽  
Well Being ◽  
Pharmaceutical Products ◽  
Domestic Market ◽  
Raw Material ◽  
Political Crisis ◽  
Pharmaceutical Manufacturer ◽  
University Graduates ◽  
Pharmaceutical Drugs

Because of the almost-instant connection with the welfare and well-being of individuals, pharmaceutical industry stands prominently as a very important factor for the improvement and progress of a healthy productive nation. These days, pharmaceutical industry thrives as one of the largest and exponentially expanding global industries. Nonetheless, millions of people in low income developing countries, have to suffer from the fatal consequences of the inaccessibility and non-availability of essential drugs. This is also happening in Yemen, where the pharmaceutical manufacturers sector have to face up to many challenges. The Yemen Drug Company (YEDCO) was founded in 1964 by the Yemeni government as it collaborated with private investors. It was endorsed as a company with the expertise in the medicinal drug marketing. YEDCO started its work by taking in drugs from foreign companies and then locally marketing and distributing them. In 1982, YEDCO built the first medicinal factory for drugs in Sana’a. Since then, seven companies were set up to manufacture medicines in Yemen. The expanding population has led to the need to have more pharmaceutical products. It may be understandable that pharmaceutical manufacturer companies are also hit by the political crisis in the country. Inadequate amount of fuel and raw material as well as low security status were some of the underlying factors behind these ill-effects in Yemen. Imported drugs make up about nearly 90% % of the pharmaceutical market compared to 10% drugs from the domestic market. This situation has led to an additional burden being shouldered by the national economy, where Yemen spends about US$263 million annually on pharmaceutical drugs, in reference to the national Supreme Drugs Authority. Although there is a very quick growth in the population and drugs consumption, the pharmaceutical industry has not been very active, where global pharmaceutical products play their role dominantly on the domestic market. The pharmaceutical production necessitates skilled human resources like university graduates. By contrast, the government and the private sector should also motivate the pharmaceutical industry and make use of the local employment

Actual issues of hygienic regulation and creation of safe working conditions at pharmaceutical manufacturing enterprises

2020 ◽  
Vol 60 (10) ◽  
pp. 640-644
Author(s):  
Vadim M. Vasilkevich ◽  
Ruslan V. Bogdanov ◽  
Elena V. Drozdova
Keyword(s):  
Pharmaceutical Industry ◽  
Working Conditions ◽  
Experimental Studies ◽  
Pharmaceutical Products ◽  
Laboratory Animals ◽  
Production Environment ◽  
Basic Principles ◽  
Toxicological Studies ◽  
Health Disorders ◽  
Safe Working

Introduction. The working conditions of pharmaceutical industry workers are characterized by the combined effect of unfavorable factors of the production environment, among which the leading one is chemical. The aim of study is to substantiate the basic principles and criteria for hygienic regulation of pharmaceutical products in their production to ensure safe working conditions for employees based on the results of their own research and existing requirements of technical regulations. Materials and methods. Analysis of working conditions and the prevalence of health disorders in pharmaceutical workers (according to literature data), toxicological studies of pharmaceutical substances on laboratory animals, scientific justification of hygiene standards in the air of the working area. Results. Among employees of the pharmaceutical industry, the predominant forms of production-related health disorders are diseases of the respiratory system, as well as skin dermatitis of allergic origin, liver and biliary tract diseases. Based on the results of experimental studies of domestic pharmaceutical products for the treatment of cardiovascular, oncological and mental diseases that have priority socio-economic significance, the basic principles and features of the practice of justifying the hygienic standards of medicines in the air of the working area are developed and systematized. Conclusions. During hygienic rationing of medicines, it is necessary to use a differentiated approach that allows, based on the analysis of information about the chemical structure, physical and chemical characteristics, production conditions, pharmacotherapeutic activity, and the results of studying the toxic effect in an experiment on laboratory animals, to determine the maximum permissible content in the air of the working area of medicines or to justify the prohibition of isolation with reasoned recommendations for their safe production.

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

Cytoprotective Agents to Avoid Chemotherapy Induced Sideeffects on Normal Cells: A Review

2019 ◽  
Vol 19 (10) ◽  
pp. 765-781
Author(s):  
Seema Rohilla ◽  
Harish Dureja ◽  
Vinay Chawla
Keyword(s):  
Adverse Effects ◽  
Anticancer Agents ◽  
Therapeutic Index ◽  
Chemotherapeutic Agents ◽  
Vital Role ◽  
Normal Cells ◽  
Normal Tissues ◽  
Organ Specific ◽  
Delay In Treatment

Anticancer agents play a vital role in the cure of patients suffering from malignancy. Though, the chemotherapeutic agents are associated with various adverse effects which produce significant toxic symptoms in the patients. But this therapy affects both the malignant and normal cells and leads to constricted therapeutic index of antimalignant drugs which adversely impacts the quality of patients’ life. Due to these adversities, sufficient dose of drug is not delivered to patients leading to delay in treatment or improper treatment. Chemoprotective agents have been developed either to minimize or to mitigate the toxicity allied with chemotherapeutic agents. Without any concession in the therapeutic efficacy of anticancer drugs, they provide organ specific guard to normal tissues.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

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