crushing production line of herbal medicines

industrial crushers - ns series crushing machine manufacturer from mumbai

High speed cutting machines with HCHCr blades (for general purpose crushing) or Hard facing (Glass crushing). Crushers are fitted with 2 rotatry and 2 stationary blades (NS range and upto 6 rotary and 4 stationary for NSM range) and has a output screen. Crushed material size can be controlled by output screen. e.g. if less than 10 mm crushed pieces are desired then screen of hole or slot of size 10 mm is selected. HCHCr blades require periodic sharpening and Hard face blades would require refurbishing or replacement (due to abrasive nature of glass).

Amey Engineers NS Series Crushing Machineare in-house designed and developed to tackle the specific disadvantages of the conventional design. The primary advantages is - Axial entry of material in the cutting chamber giving reduced throw back and faster output also no requirement of pushing material in the cutting chamber (This is a major disadvantage of conventional design). Can cut light weight plastic items more efficiently than conventional design. Uses Special alloy material (HCHCr) blades hardened to 60+ RC. Ease of replacement/sharpening of blade. Comparatively less wastage of blade unused area. Side facing output chute makes collection of crushed item easy. Better operator safety mechanism. Also with minor change the same machine can be used for Glass crushing or chemical lumps crushing and even organic material grinding.

Amey Engineers provide a wide range of NS-500 Series Industrial Crushers, designed to crush and reduce large solid chunks of material into smaller chunks. These products are based on the principle of crushing without rubbing minimum dust .

Amey Engineers provide a wide range of NS-220 Industrial Crushers, designed to crush and reduce large solid chunks of material into smaller chunks. These products are based on the principle of crushing without rubbing minimum dust .

Amey Engineers provide a wide range of Amey Engineers Fine Crusher, designed to crush and reduce large solid chunks of material into smaller chunks. These products are based on the principle of crushing without rubbing minimum dust .

about us

Add: 18 Taiyangshan Road, Changkou Industrial Park, Fuyang City, Hangzhou City, Zhejiang, China Sales Tel: (+86) / 63460822 Sales Fax: (+86) After-sales Service Tel: (+86) After-sales Service Fax: (+86)

Fuyang Kanghua Pharmaceutical Machinery Co.,Ltd. (formerly: Hangzhou Fuyang Kanghua Machinery Factory) was established in 2001, is set production research and the integration of Chinese herbal medicines and Pieces pre-treatment processing equipment manufacturing enterprises. Companies adhering to the basis of product quality, customer service-oriented, research and innovation for the purpose of stamina, while rapid development of enterprises, and strive to build a new R & D center to develop a modern, innovative equipment for the task to ensure that products remain the industry's advanced ranks , the company has owned 23 patents, is the national innovation project support units, Hangzhou Eagles program units. 2011 invested 30 million yuan to create a new Bozhou Kanghua Pharmaceutical Machinery Co., Ltd. in Bozhou, in early 2012 formally put into production. Bozhou Kanghua inherit Fuyang Kanghua customer-God, to quality of survival of the concept, according to borrow more than 10,000 square meters of modern plant and advanced CNC production line, using Fuyang Kanghua advanced technology, the scale production, in line with GMP certification can provide modern equipment suitable for the pharmaceutical, food, agricultural processing and other industries, more than 3,000 Taiwan (sets), to meet the needs of domestic and foreign enterprises. Strong technical force, modern standard workshops, advanced production technology. Fuyang Kanghua Pharmaceutical Machinery Co., Ltd. to create more than a decade, has become China's major production base of Chinese pre-treatment equipment, able to independently produce more than thirty varieties, more than 60 standard models of Chinese medicine processing equipment, Our products are widely used in pharmaceutical, food, agricultural and sideline products processing, annual output of more than 1,000 Taiwan (sets), more than 1,300 users across the country 32 provinces, municipalities and autonomous regions, and exported to Hong Kong, Taiwan, Japan, Singapore, Vietnam India, Malaysia, Russia, the United States, France, Chile, South Africa and other regions and countries; Panzhihua Li Xin Pharmaceutical, Guizhou magic Group, Henan Light Group, Lei Yun Shang Pharmaceutical, Guilin Sanjin, Tsumura Shenzhen, Guangzhou, one Pharmaceutical, Yunnan Baiyao Group, Kyushu Medical Group, Yunnan East Financial Dianxi medicines Logistics Management Co., Lanzhou Foci, Beijing Tongrentang, Hangzhou Hu Qing Yu Tang, Tianjin Tasly, Jiangxi Hui Ren, Lizhu Group, Harbin Pharmaceutical Group, Chinese Herbal Medicine Kangqiao Shanghai, Shenzhen Heshun Hall and other famous enterprises are using my company's equipment. The company has more than 3000 square meters of standard production plant, complete gold processing plant, sheet metal shop, welding shop, assembly equipment and experienced production workers, equipped with modern office facilities. Enterprises always attached importance to scientific and technological progress, there is a strong research and development team, focusing on new product development, so there are two or three new products to market each year. Enterprise has been rated as Zhejiang Province, Hangzhou, "high-tech enterprise", "Zhejiang SME", "Hangzhou Hi-tech Enterprise" and "Fuyang City, patent model enterprise" and so on. 2008 passed the ISO9001 quality system certification. Set up an office within the enterprise, finance, production, quality control, research and development centers, information, marketing, supply and other departments to ensure the orderly conduct of production, quality, sales and other business activities. In order to ensure the needs of users to produce, where to buy our equipment, have signed a pre-service undertaking, in equipment installation, technical training, equipment inspection, equipment warranty, spare parts and related technical support, (that is, the user design process, according to the plant characteristics and requirements of customers design and manufacture of a specific device) and other aspects of detailed commitments, in the form of payment, in order to show good faith, the company gave customers a certain proportion of the margin left in the year. For this reason, companies received praise and trust of users. In order to support the implementation of Chinese machinery industry, technological progress and mechanization of Chinese Herbal Medicine, to contribute to standardization, the company organized a certain technology, research and development of advanced, high automation, energy saving, emission reduction, low carbon, practical equipment into the market, to further meet the domestic and foreign markets and the majority of users.

Add: 18 Taiyangshan Road, Changkou Industrial Park, Fuyang City, Hangzhou City, Zhejiang, China Sales Tel: (+86) / 63460822 Sales Fax: (+86) After-sales Service Tel: (+86) After-sales Service Fax: (+86)

pharmaceutical and medicine manufacturing industries: career, outlook and education information

Manufacturing Technician in Burlington, MA AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Manufacturing Technician I is an ...

The pharmaceutical and medicine manufacturing industry develops and produces a variety of medicinal and other health-related products that save the lives of millions of people from various diseases and permits many people suffering from illness to recover to lead productive lives.

Goods and services. Thousands of medications are available today for diagnostic, preventive, and therapeutic uses. In addition to aiding in the treatment of infectious diseases such as pneumonia, tuberculosis, malaria, influenza, and sexually transmitted diseases, these medicines also help prevent and treat cardiovascular disease, asthma, diabetes, hepatitis, cystic fibrosis, and cancer. For example, anti-nausea drugs help cancer patients endure chemotherapy; clot-buster drugs help stroke patients avoid brain damage; and psychoactive drugs reduce the severity of mental illness for many people. Antibiotics and vaccines have dramatically reduced the occurrences of such diseases as diphtheria, syphilis, and whooping cough. Discoveries in veterinary drugs have controlled various diseases, some of which are transmissible to humans.

The U.S. pharmaceutical industry has achieved worldwide prominence through research and development (R&D) on new drugs, and spends a relatively high proportion of its revenue on R&D compared with other industries. Each year, pharmaceutical industry testing involves millions of compounds, yet may eventually yield fewer than 100 new prescription medicines.

For the majority of firms in this industry, the actual manufacture of drugs is the last stage in a lengthy process that begins with scientific research to discover new products and to improve or modify existing ones. The R&D departments in pharmaceutical and medicine manufacturing firms start this process by seeking and rapidly testing libraries of thousands to millions of new chemical compounds with the potential to prevent, combat, or alleviate symptoms of diseases or other health problems. Scientists use sophisticated techniques, including computer simulation, combinatorial chemistry, and high-throughput screening (HTS), to hasten and simplify the discovery of potentially useful new compounds.

Most firms devote a substantial portion of their R&D budgets to applied research, using scientific knowledge to develop a drug targeted to a specific use. For example, an R&D unit may focus on developing a compound that will effectively slow the advance of breast cancer. If the discovery phase yields promising compounds, technical teams then attempt to develop a safe and effective product based on the discoveries.

To test new products in development, a research method called "screening" is used. To screen an antibiotic, for example, a sample is first placed in a bacterial culture. If the antibiotic is effective, it is next tested on infected laboratory animals. Laboratory animals also are used to study the safety and efficacy of the new drug. A new drug is selected for testing on humans only if it either promises to have therapeutic advantages over drugs already in use or is safer. Drug screening is a laborious and costly processonly 1 in every 5,000 to 10,000 compounds screened eventually becomes an approved drug.

After laboratory screening, firms conduct clinical investigations, or "trials," of the drug on human patients. Human clinical trials normally take place in three phases. First, medical scientists administer the drug to a small group of healthy volunteers to determine and adjust dosage levels, and monitor for side effects. If a drug appears useful and safe, additional tests are conducted in two more phases, each phase using a successively larger group of volunteers or carefully selected patients. The final round of testing often involves a very large panel, sometimes upwards of 10,000 individuals.

After a drug successfully passes animal and clinical tests, the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) must review the drug's performance on human patients before approving the substance for commercial use. The entire process, from the first discovery of a promising new compound to FDA approval, can take over a decade and cost hundreds of millions of dollars.

After FDA approval, problems of production methods and costs must be worked out before manufacturing begins. If the original laboratory process of preparing and compounding the ingredients is complex and too expensive, pharmacists, chemists, chemical engineers, packaging engineers, and production specialists are assigned to develop a manufacturing process economically adaptable to mass production. After the drug is marketed, new production methods may be developed to incorporate new technology or to transfer the manufacturing operation to a new production site.

Most pharmaceutical production plants are highly automated. Milling and micronizing machines, which pulverize substances into extremely fine particles, are used to reduce bulk chemicals to the required size. These finished chemicals are combined and processed further in mixing machines. The mixed ingredients may then be mechanically capsulated, pressed into tablets, or made into solutions. One type of machine, for example, automatically fills, seals, and stamps capsules. Other machines fill bottles with capsules, tablets, or liquids, and seal, label, and package the bottles.

Quality control and quality assurance are vital in this industry. Many production workers are assigned full time to quality control and quality assurance functions, whereas other employees may devote part of their time to these functions. For example, although pharmaceutical company sales representatives, often called detailers, work primarily in marketing, they engage in quality control when they assist pharmacists in checking for outdated products.

Industry organization. The pharmaceutical and medicine manufacturing industry consists of over 2,500 places of employment, located throughout the country. R&D laboratories perform the work of drug discovery and development, while manufacturing plants produce the final drugs for consumers. Most R&D laboratories are located separately from manufacturing plants, but some labs and production plants are integrated.

There are three main types of pharmaceutical companies. Large, or mainline, pharmaceutical companies are established firms that have many approved drugs already on the market. These companies often have significant numbers of R&D laboratories and manufacturing plants throughout the Nation and around the world. In contrast, smaller pharmaceutical companies are usually newer firms that often do not have any approved drugs on the market. As a result, these firms almost exclusively perform R&D. In addition to developing their own drugs, some small pharmaceutical companies perform contract research for other pharmaceutical companies. Finally, generic pharmaceutical companies manufacture drugs that are no longer protected by patents. Because their products are all established drugs, they devote fewer resources to R&D and more to manufacturing.

Recent developments. Advances in biotechnology are transforming drug discovery and development. Bioinformatics, a branch of biotechnology using information technologies to work with biological data like DNA, is a particularly dynamic new area of work. Scientists have learned a great deal about human genes, but the real worktranslating that knowledge into viable new drugshas only recently begun. So far, millions of people have benefited from medicines and vaccines developed through biotechnology, and several hundred new biotechnologically-derived medicines are currently in the pipeline. These new medicines, all of which are in human clinical trials or awaiting FDA approval, include drugs for cancer, infectious diseases, autoimmune diseases, neurologic disorders, and HIV/AIDS and related conditions.

Many new drugs are expected to be developed in the coming years. Advances in technology and the knowledge of how cells work will allow pharmaceutical and medicine manufacturing makers to become more efficient in the drug discovery process. New technology allows life scientists to test millions of drug candidates far more rapidly than in the past. Other new technology, such as regenerative therapy, also will allow the natural healing process to work faster, or enable the regrowth of missing or damaged tissue. In addition, technology based on the study of genes is being explored to develop vaccines to prevent or treat diseases that have eluded traditional vaccines, such as AIDS, malaria, tuberculosis, and cervical cancer.

Advances in manufacturing processes are also impacting the industry. While pharmaceutical manufacturers have long devoted resources to new drug development as a source for future profits, firms are increasingly realizing that improvements throughout the drug pipeline are needed to stay competitive. Along with other manufacturing industries, pharmaceutical manufacturers are realizing that quality products can best be produced when quality improvements occur at all stages and when processes are continually updated with the latest technologies and methods. Controlling the product flow through the supply chain also ensures that valuable resources do not sit idle but are put to work, and that final products reach consumers without delay.

Hours. In 2008, production workers in pharmaceutical and medicine manufacturing worked an average of 40.9 hours per week, compared with 33.6 for workers in all industries. Some employees work in plants that operate around the clockthree shifts a day, 7 days a week. In most plants, workers receive extra pay when assigned to the second or third shift. Because drug production is subject to little seasonal variation or fluctuation in economic activity, work is steady.

Work environment. Working conditions in pharmaceutical plants are better than those in most other manufacturing plants, and work-related injuries are rare. Much emphasis is placed on keeping equipment and work areas clean because of the danger of contamination. Plants usually are air-conditioned, well lighted, and quiet. Ventilation systems protect workers from dust, fumes, and disagreeable odors. Special precautions are taken to protect the relatively small number of employees who work with infectious cultures and poisonous chemicals. With the exception of work performed by material handlers and maintenance workers, most jobs require little physical effort.

Pharmaceutical and medicine manufacturing provided 289,800 wage and salary jobs in 2008. Pharmaceutical and medicine manufacturing establishments usually employ many workers. About 87 percent of this industry's jobs in 2008 were in establishments that employed more than 100 workers. Over half of all jobs are in California, New Jersey, Puerto Rico, Pennsylvania, and New York.

Under the North American Industry Classification System (NAICS), workers in research and development (R&D) establishments that are not part of a manufacturing facility are included in a separate industryresearch and development in the physical, engineering, and life sciences. However, due to the importance of R&D work to the pharmaceutical and medicine manufacturing industry, drug-related R&D is discussed in this statement even though a large proportion of pharmaceutical industry-related R&D workers are not included in the employment data.

About 31 percent of all jobs in the pharmaceutical and medicine manufacturing industry are in professional and related occupations, mostly scientists and science technicians. About 27 percent of jobs are in production occupations, including both low skilled and high skilled jobs. The remaining jobs are primarily management, and office and administrative support occupations (table 1).

Professional and related occupations. Scientists, engineers, and technicians conduct research to develop new drugs. Others work to streamline production methods and improve environmental and quality control. Life scientists are among the largest scientific occupations in this industry. Most of these scientists are biological and medical scientists who produce new drugs using biotechnology to recombine the genetic material of animals or plants. Biological scientists normally specialize in a particular area. Biologists and bacteriologists study the effect of chemical agents on infected animals. Biochemists study the action of drugs on body processes by analyzing the chemical combination and reactions involved in metabolism, reproduction, and heredity. Microbiologists grow strains of microorganisms that produce antibiotics. Physiologists investigate the effect of drugs on body functions and vital processes. Pharmacologists and zoologists study the effects of drugs on animals. Virologists grow viruses, and develop vaccines and test them in animals. Botanists, with their special knowledge of plant life, contribute to the discovery of botanical ingredients for drugs. Other biological scientists include pathologists, who study normal and abnormal cells or tissues, and toxicologists, who are concerned with safety, dosage levels, and the compatibility of different drugs. Medical scientists, who also may be physicians, conduct clinical research, test products, and oversee human clinical trials.

The work of physical scientists, particularly chemists, also is important in the development of new drugs. Combinatorial and computational chemists create molecules and test them rapidly for desirable properties. Organic chemists, often using combinatorial chemistry, then combine new compounds for biological testing. Physical chemists separate and identify substances, determine molecular structure, help create new compounds, and improve manufacturing processes. Radiochemists trace the course of drugs through body organs and tissues. Pharmaceutical chemists set standards and specifications for the form of products and for storage conditions; they also see that drug labeling and literature meet the requirements of State and Federal laws. Analytical chemists test raw and intermediate materials and finished products for quality.

Science technicians, such as biological and chemical technicians, play an important part in research and development of new medicines. They set up, operate, and maintain laboratory equipment, monitor experiments, analyze data, and record and interpret results. Science technicians usually work under the supervision of scientists or engineers.

Although engineers account for a small fraction of scientific and technical workers, they make significant contributions toward improving quality control and production efficiency. Chemical engineers design equipment and devise manufacturing processes. Bioprocess engineers, who are similar to chemical engineers, design fermentation vats and various bioreactors for microorganisms that will produce a given product. Industrial engineers plan equipment layout and workflow to maintain efficient use of plant facilities.

Production occupations. Among the larger of the production occupations, assemblers and fabricators perform various assembly tasks in teams, rotating through the different tasks rather than specializing in a single task. They also may decide how the work is to be assigned and how different tasks are to be performed.

Other production workers specialize in one part of the production process. Chemical processing machine setters, operators, and tenders, such as pharmaceutical operators, control machines that produce tablets, capsules, ointments, and medical solutions. Included among these operators are mixing and blending machine setters, operators, and tenders, who tend milling and grinding machines that reduce mixtures to particles of designated sizes. Extruding, forming, pressing, and compacting machine setters, operators, and tenders tend tanks and kettles in which solutions are mixed and compounded to make up creams, ointments, liquid medications, and powders. Crushing, grinding, polishing, mixing, and blending workers operate machines that compress ingredients into tablets. Coating, painting, and spraying machine setters, operators, and tenders, often called capsule coaters, control a battery of machines that apply coatings that flavor, color, preserve, or add medication to tablets, or control disintegration time. Throughout the production process, inspectors, testers, sorters, samplers, and weighers ensure consistency and quality. Tablet testers, for example, inspect tablets for hardness, chipping, and weight to assure conformity with specifications. After the drug is prepared and inspected, it is bottled or otherwise packaged by packaging and filling machine operators and tenders.

Plant workers who do not operate or maintain equipment perform a variety of other tasks. Some drive industrial trucks or tractors to move materials around the plant, load and unload trucks and railroad cars, or package products and materials by hand.

Other occupations. At the top of the managerial group are executives who make policy decisions concerning matters of finance, marketing, and research. Other managerial workers include natural sciences managers and industrial production managers.

Workers in office and administrative support occupations include secretaries and administrative assistants, general office clerks, and others who keep records on personnel, payroll, raw materials, sales, and shipments.

Sales representatives, wholesale and manufacturing, describe their company's products to physicians, pharmacists, dentists, and health services administrators. These workers serve as lines of communication between their companies and clients.

Training requirements for jobs in the pharmaceutical and medicine manufacturing industry range from a few hours of on-the-job training to years of formal education plus job experience. However, because of the large number of workers in professional occupations, bachelors and graduate degrees are common.

Scientific and engineering occupations. A bachelor of science degree is typically the minimum requirement for these workers, although scientists involved in research and development usually have a master's or doctoral degree. A doctoral degree is generally the minimum requirement for medical scientists, and those who administer drug or gene therapy to patients in clinical trials must have a medical degree. Because biotechnology is not one discipline, but the interaction of several disciplines, the best preparation for work in biotechnology is training in a traditional biological science, such as genetics, molecular biology, biochemistry, virology, or biochemical engineering. Individuals with a scientific background and several years of industry experience may eventually advance to managerial positions. Some companies offer training programs to help scientists and engineers keep abreast of new developments in their fields and to develop administrative skills. These programs may include meetings and seminars with consultants from various fields. Many companies encourage scientists and engineers to further their education; some companies provide financial assistance or full reimbursement of expenses for this purpose. Publication of scientific papers also is encouraged.

Science technician occupations. To fill these jobs, most companies prefer to hire graduates of technical institutes or community colleges or those who have completed college courses in chemistry, biology, mathematics, or engineering. Some companies, however, require science technicians to hold a bachelor's degree in a biological or chemical science. In many firms, newly hired workers begin as laboratory helpers or aides, performing routine jobs such as cleaning and arranging bottles, test tubes, and other equipment.

The experience required for higher-level technician jobs varies from company to company. Usually, employees advance over a number of years from assistant technician, to technician, to senior technician, and then to technical associate, or supervisory technician.

Production occupations. Manufacturers usually hire inexperienced workers and train them on the job, although workers with some postsecondary training, particularly in manufacturing, are preferred. Beginners in production jobs assist experienced workers and learn to operate processing equipment. With experience, employees may advance to more skilled jobs in their departments.

The industry places a heavy emphasis on continuing education for employees, and many firms provide classroom training in safety, environmental and quality control, and technological advances. Many companies encourage production workers to take courses related to their jobs at local schools and technical institutes. College courses in chemistry and related areas are particularly encouraged for highly skilled production workers who operate sophisticated equipment. Some companies reimburse workers for part, or all, of their tuition. Skilled production workers with leadership ability may advance to supervisory positions.

Sales and related occupations. Pharmaceutical manufacturing companies prefer to hire college graduates, particularly those with strong scientific backgrounds. In addition to a 4-year degree, most newly employed pharmaceutical sales representatives complete rigorous formal training programs revolving around their company's product lines.

Employment change. The number of wage and salary jobs in pharmaceutical and medicine manufacturing is expected to increase by 6 percent over the 2008-18 period, compared with 11 percent projected for all industries combined. Even during fluctuating economic conditions, demand is expected to remain strong for this industry's products, including the diagnostics used in hospitals, laboratories, and homes, the vaccines used routinely on infants and children, analgesics and other symptom-easing drugs; antibiotics and other drugs for life-threatening diseases, and "lifestyle" drugs for the treatment of nonlife-threatening conditions.

The use of drugs, particularly antibiotics and vaccines, has helped to eradicate or limit a number of deadly diseases, but many others, such as cancer, Alzheimer's, and heart disease, continue to elude cures. Ongoing research and the manufacture of new products to combat these and other diseases will continue to contribute to employment growth. Demand also is expected to increase as the population expands because many of the pharmaceutical and medicine manufacturing industry's products are related to preventive or routine healthcare, rather than just illness. The growing number of older people, who tend to consume more of all types of healthcare services, will further stimulate demandalong with the growth of both public and private health insurance programs, which increasingly cover the cost of drugs and medicines.

Another factor propelling demand is the increasing popularity of "lifestyle" drugs. These drugs treat symptoms of chronic nonlife-threatening conditions resulting from aging or genetic predisposition and can enhance one's self-confidence or physical appearance. Other factors expected to increase the demand for drugs include greater personal income and the rising health consciousness and expectations of the general public.

Despite the increasing demand for drugs, several factors will limit employment growth in the industry. Drug producers and buyers are placing more emphasis on cost effectiveness, due to the extremely high costs of developing new drugs. Competition from the producers of generic drugs also will put pressure on many firms in this industry as more brand-name drug patents expire. On the manufacturing side, continuing improvements in manufacturing processes will improve productivity in pharmaceutical plants, while many companies are also manufacturing more of their products overseas.

Strong demand is anticipated for professional occupationsespecially for life and physical scientists engaged in R&D, the backbone of the pharmaceutical and medicine manufacturing industry. Much of the basic biological research done in recent years has resulted in new knowledge, including the successful identification of genes. Life and physical scientists will be needed to take this knowledge to the next stage, which is to understand how certain genes function so that gene therapies can be developed to treat diseases. Computer specialists such as systems analysts, biostatisticians, and computer support specialists also will be in demand as disciplines such as biology, chemistry, and electronics continue to converge and become more interdisciplinary, creating demand in rapidly emerging fields such as bioinformatics and nanotechnology.

Steady demand also is projected for production occupations. Employment of office and administrative support workers is expected to grow more slowly than the industry as a whole, as companies streamline operations and increasingly rely on computers.

Job prospects. Prospects should be favorable, particularly for life scientists with a doctoral degree. Unlike many other manufacturing industries, the pharmaceutical and medicine manufacturing industry is not highly sensitive to changes in economic conditions. Even during periods of high unemployment, work is likely to be relatively stable in this industry, because consumption of medicine does not vary greatly with economic conditions. Additional openings will arise from the need to replace workers who transfer to other industries, retire, or leave the workforce for other reasons.

Industry earnings. Earnings of workers in the pharmaceutical and medicine manufacturing industry are higher than the average for all manufacturing industries. In 2008, production or nonsupervisory workers in this industry averaged $821 a week, while those in all manufacturing industries averaged $724 a week. Wages in selected occupations in pharmaceutical and medicine manufacturing appear in table 2.

Computer systems analysts, sometimes called systems architects, study an organizations current computer systems and procedures, and design solutions to help the organization operate more efficiently and effectively.

Natural sciences managers supervise the work of scientists, including chemists, physicists, and biologists. They direct activities related to research and development, and coordinate activities such as testing, quality control, and production.

quality transitivity and traceability system of herbal medicine products based on quality markers - sciencedirect

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of quality marker (Q-marker) lays basis for establishing an independent process quality control system for herbal products.

To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products.

Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed.

Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control.

The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain.

The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production.

pharmaboardroom | traditional medicines & otc products: brazil

A guide to the state-of-play regarding traditional medicines and over-the-counter (OTC) products in Brazil. Prepared in association with Trench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here.

Resolution RDC No. 26/2014 provides for traditional and herbal drugs requirements. These drugs are subject to registration, simplified registration (those included on the list of the Normative Instruction No. 2/2014 or on the Community herbal monographs with well-established use) or notification (those with active ingredient contained in the Herbal Medicines National Formulary of Brazilian Pharmacopoeia and Pharmacopoeias recognized by ANVISA), depending on its formulation. In order to submit the product to ANVISAs analysis is necessary to present proof of safety use (non-clinical and clinical toxicology) and of therapeutic effectiveness (non-clinical and clinical pharmacology) of the drug.

Herbal and traditional drugs must comply with labeling and packaging limitations set forth in ANVISA Resolution No. 71/2009. Labels must only contain accurate, adequate and safe information, among other specific information depending on the type of product. Note however that all claims included on the products label must be based on the studies and/or on the pharmacopoeia.

Those that offer low risk to the consumers (and are included on the list of the ANVISAs Resolution No. 107/2016) are exempted from registration and only need to comply with the procedure of notification, which required the submission of a reduced number of documents capable of attesting to the quality and safety of the drug.

As mentioned (on Question 6 of Regulatory, Pricing and Reimbursement), there is also the simplified procedure for the registration, which applies not only for generics, but also for similar, specific, dynamized, phytotherapeutic and biological drugs that have the same production line, same manufacturer, same technical and clinical reports, the same composition of another drug already registered by the regular procedure before ANVISA, but with a different name, labeling packaging and registration holder. The analysis/review by ANVISA of the documents is faster (when compared with the regular procedure) since the documents were already analyzed by ANVISA on a previous (regular) procedure.

Finally, there is also the OTCs drugs that are subject to the regular procedure (provided for in ANVISAs Resolution No. 200/2017, which determined the minimum requirements for obtaining and renewing registration of drugs with synthetic and semi-synthetic active principles, classified as new, generic and similar), through this procedure the complete dossier will need to be submit.

Only pharmacies and drugstores, with technical responsible present during all time of the operation, can dispense drugs. Note that remote means such as telephone and internet are also allowed, provided that the pharmacies and drugstores observe the restrictions set forth in the applicable rules.

Biosimilars & biologics in Brazil a comprehensive legal overview. Prepared in association withTrench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, a biosimilar drug is not considered to be the same as a generic drug. There are specific rules governing generic and similar drugs, and they

Want to know more about localization in Brazil? Read on! Prepared in association withTrench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes, there are rules encouraging localization in Brazil, such as the Federal Law No.

The key facts about orphan drugs & rare diseases in Brazil. Prepared in association withTrench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. What is the definition of Rare Diseases in your country? According to Resolution RDC No. 205/2017 issued by the National Health of Surveillance Agency (ANVISA), rare diseases are defined as diseases with incidence of up to 65

All about cannabinoid drugs, medicinal cannabis and opioid drugs in Brazil. Prepared in association withTrench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? The National Health Surveillance Agency (ANVISA) recently approved (on December 11, 2019) the Resolution RDC No. 327/19 defining the procedure for granting the Sanitary Authorization for manufacturing and

A brief insight into upcoming regulatory reforms in Brazilian pharma.Prepared in association withTrench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. Are there proposals for reform or significant change to the healthcare system? There are plenty of Law projects under discussion. Before ANVISA there are two relevant rules under public consultation, one to regulate Good Practices for Pharmacovigilance and other

An overview of the legal framework for patents and trademarks for pharmaceuticals in Brazil.Prepared in association withTrench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. What are the basic requirements to obtain patent and trademark protection? Industrial Property Rights are regulated in Brazil through Federal Law No. 9,279/1996 (IP Law). Under its Article 8, the main requirements for the grant

The ins and outs of product liability in Brazilian pharma.Prepared in association withTrench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. What types of liability are recognized in your jurisdiction? The scope of liability for suppliers and the standards for consumer protection in Brazil are, in some cases, more severe than the consumer rules applicable in other countries. The Brazilian

Everything you need to know about the marketing, manufacturing, packaging & labeling and advertising of pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The company should be licensed before ANVISA (at the

The requirements for conducting preclinical and clinical trials in Brazil. Prepared in association withTrench, Rossi e Watanabeone of Brazils most prestigious law firms, this is an extract fromThe Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. 2. How are clinical trials funded? Clinical trials are funded by sponsor (individual or legal entity, public or private,

A brief legal overview of the situation regarding the regulation, pricing and reimbursement of pharmaceuticals in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazils most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Brazil, the authorities are the National Health of Surveillance Agency (ANVISA),