Pharmacy: Interpreting services & specialist translations of pharmaceutical texts
- Audits & inspections by foreign licensing authorities
- Production of pharmaceuticals and APIs
- Requirement specifications
- Manuals of machines in pharmaceutical production
- Documentation in the areas of quality assurance and quality control
- Calibration results of devices
- Vaccine and drug design
- Guidelines & directives
- Manufacturing licences
- Air-conditioning, cooling and analysis technology in pharmaceutical laboratories
- Temperature-regulated storage and logistics
- Qualification of clean rooms and systems
- Microbiological tests
- Package leaflets
- Staff training
- Sampling plans
- Production processes
- Examinations of air and water treatment plants
- Pest control
- Training documents
- Standard operating procedures (SOPs)
- Research reports
- Validation results
- Regulations for disinfection, personnel hygiene, storage, channeling processes
We also provide specialist translation and interpreting services for the following pharmaceutical fields:
- Clinical pharmacy
- Pharmaceutical biology
- Pharmaceutical biotechnology
- Pharmaceutical chemistry
- Pharmaceutical technology
A brief excursion into the history of pharmacy
The term "pharmacy" means study of medicines and is derived from the Greek word "pharmakon" (remedy, potion). Accordingly, pharmacy deals with the development, production, quality assurance, effect, safety, use and storage of medicines. It is an interdisciplinary science. Pharmacists must therefore have sound knowledge of the various natural sciences, such as biology and chemistry, but also medical expertise.
Origin of modern pharmacy
Modern pharmacy has its roots in the early medicine of Roman antiquity, although it was also strongly influenced by the Byzantine and Islamic-Arabic culture. As an independent scientific discipline, pharmacy, as we know it today, has only existed since the 17th to 18th century.
The development of pharmacies
After the decline of the Western Roman Empire, the treatment of diseases and the production of medicines was the task of educated monks and nuns for a long time. The first "real" pharmacies most likely originated in southern Italy in the 12th century and probably developed from the spice and herb shops that had previously been widespread. The first official collection of laws in which pharmacies were explicitly listed was the so-called Liber Augustalis, a legal code written by Emperor Frederick II (1194-1250) for the Kingdom of Sicily. The first legal text that indicates the existence of public pharmacies in the German-speaking area is the Nuremberg Pharmacy Oath (1338/1360). It states that
"every pharmacist [should] swear that he will produce for the poor and the rich, without endangering them, what he has been verbally ordered to produce or what has been written down for him. For his work, he may receive such remuneration that he may, in his conscience, have a modest profit for his food and work".
It can be assumed that pharmacies initially existed only in important trading cities, such as Mainz, Cologne, Basel or Heidelberg. However, it took another 200 years before pharmacies actually became an integral part of the urban healthcare system. By the 17th century, not only had the number of pharmacies multiplied, but the profession of pharmacist had also increasingly gained social prestige.
Further development of pharmacy
The more than 2000-year-old concept of pharmacy, which was primarily based on the healing practices of antiquity, experienced a decisive turn in the 16th century under the influence of the renowned Swiss doctor and natural philosopher Theophrastus Bombastus von Hohenheim, also known as Paracelsus: while drugs had previously been produced from many natural individual substances, he expanded the range of pharmaceutical products available at that time to include new iatrochemical medicines. The result was a constant differentiation of pharmaceutical activities. An important focus from now on was the chemical production of various ointments, creams or drops in the pharmacy laboratory. At the beginning of the 19th century, producing pharmaceuticals in addition to performing the regular tasks in a pharmacy became too costly and time-consuming. This led to the establishment of the first industrial enterprises for the production of active ingredients and medicines.
Regulation of pharmaceutical training
While private educational institutions initially undertook the technical and scientific training of pharmacists, a university degree in pharmacy has been required to work in the pharmaceutical field in Germany since the 19th century.
Particularities of specialist pharmaceutical translations
Pharmaceutical translations and interpreting services do not only comprise medicine and natural sciences, such as biology, microbiology, physics and chemistry, but also technology, logistics and at times even law. This makes pharmacy one of the most complex specialist fields, in which only experienced specialist translators and interpreters can and should translate texts and information. The linguist has to be familiar with scientific contexts in the development and production of drugs and pharmaceuticals as well as their effects. Moreover, the language expert needs to have in-depth knowledge of production and logistics to understand and translate all processes of the production line from the function of small machines and water treatment to storage management.
Raw materials, excipients and active ingredients, their production, composition and fields of application as well as their effects are the pillars of pharmacy. Pharmaceutical companies, universities and supervisory authorities and many other organizations invest a lot of time and money in this research and the associated quality assurance and often publish the results internationally. The flawless specialist translation of these texts and documents is crucial and paramount. If only one comma in the translation is in the wrong place or one term is incorrect, it can have far-reaching and possibly fatal consequences. In order to prevent this and to guarantee the flawless quality of the specialist translation, the correct use and linguistic transfer of specialized terminology, we only employ highly competent specialist translators with many years of experience in the pharmaceutical field. To guarantee the specialist pharmaceutical and linguistic accuracy, a native-speaking expert always proofreads the translation – as per the saying “trust but verify”. When it comes to the translation of your specialized texts, we take this to heart and do not take any risks – quite the contrary: we minimize all possible sources of risk or even eliminate them completely. With us, your specialist translation is in competent and experienced hands.
GMP & production lines
GMP is the abbreviation for Good Manufacturing Practice in the pharmaceutical sector. This particularly includes guidelines for quality assurance of the production processes and environment in the production of pharmaceuticals and APIs (active pharmaceutical ingredients) and the associated quality control.
The highest priority is, of course, to ensure the quality, harmlessness and tolerance of a drug for the consumer. To this end, mandatory quality requirements must be adhered to during production, processing, packing and storage. GMP compliant quality management systems include document, deviation, change and risk management, qualification of the equipment, validation of processes and methods, staff training and audits. All processes must be documented and checked with meticulous precision to deliver an effective, low-risk and high-quality end product. Pharmaceutical translators or interpreters have to be aware of the significance of every single contributing step and they must have in-depth knowledge of the matter in order to correctly and accurately translate the contents in this field.
GMP guidelines also regulate complex water treatment processes, air purification, microbiological test methods, bottling, packing, storage and transport of pharmaceuticals, sampling, hygiene as well as operation and maintenance of miscellaneous equipment in the laboratory or production line.
During GMP inspections, individual equipment, machines and systems are inspected as well as entire production lines used for the production of APIs and pharmaceuticals. In the pharmaceutical industry, an important factor during production is precise and flawlessly functioning technology, as mistakes in the development and production of pharmaceuticals must simply be avoided. For this reason, production lines, i.e. completely automated production systems for processing production steps, are used. Thanks to these sophisticated systems, the human element as a potential source of risk is removed for the most part and contamination due to incorrect handling, for example, can thus be ruled out. Yet, those highly complex machine systems still have to be operated and maintained by employees. These employees, however, are thoroughly trained to operate these production systems and go through multiple training courses to achieve the required qualification.
These highly complex processes and inspections and their documentation can only be transferred into the target language by an experienced professional in this field. In order to completely rule out misunderstandings and ambiguities and to guarantee the impeccable quality of your specialist translation, we at AP Fachübersetzungen only work with highly competent specialist translators and interpreters who have the necessary background knowledge in the pharmaceutical industry as well as many years of experience in this field.
Licensing and supervisory authorities
Under this menu item, we have gathered interesting facts about some of the numerous licensing and supervisory authorities in the pharmaceutical industry for you.
In Germany, the production of pharmaceuticals is strictly regulated by the German Medicinal Products Act (Arzneimittelgesetz, AMG) and the German Ordinance for the Manufacture of Medicinal Products and Active Agents (Arzneimittel- und Wirkstoffherstellungsverordnung, AMWHV).
Many authorities who work together in the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) are responsible for the supervision of the production of pharmaceuticals and ongoing clinical studies in the Federal Republic of Germany. This authority is the coordination center of the German Länder (federal states) for human and veterinary medical products. Its responsibilities include quality assurance in the supervision and examination of drugs, e-commerce with pharmaceuticals as well as their advertisement, licensing requirements and processes for laboratories and certification authorities in the pharmaceutical industry.
However, central tasks are carried out by other higher federal authorities. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), for example, is responsible for licensing and supervision of pharmaceuticals, risk identification and risk assessment of medical devices as well as monitoring the distribution of narcotic and basic substances. Moreover, the institute carries out scientific research in the field of pharmacy.
Another institution worth mentioning is the Paul-Ehrlich-Institute, the federal institute for vaccines and biomedical drugs. It is subordinate to the Federal Ministry of Health and responsible for the approval of vaccines and biomedical pharmaceuticals, the approval of clinical tests, batch checks and releases, the registration and assessment of side effects and applied research, among others.
These complex quality assurance structures in the pharmaceutical industry ensure that only high-quality products which meet all requirements are approved and launched on the market.
The GMP directive of the European Union contains guidelines for GMP compliant production of pharmaceuticals in the member states of the EU.
Issuing marketing authorizations for pharmaceuticals is one of the duties of the European Commission. The European Medicines Agency (EMA), in contrast, is responsible for the scientific evaluation, supervision and safety check of medicines in the EU. Another organ which is important in the pharmaceutical industry is the European Directorate for the Quality of Medicines (EDQM), which is subordinate to the Council of Europe. The EDQM is responsible for writing and continuously developing the European pharmacopoeia as well as the quality control of substances used in pharmaceuticals; to this end, it has its own laboratories.
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) reports to the Ministry of Health and is responsible for the control and supervision of the healthcare system. This authority is in charge of inspections and audits to ensure the quality and safety of medical practice, the circulation of drugs and medical devices, the inspection of healthcare facilities, drug pricing, the implementation of public programs to modernize the healthcare system, the registration and monitoring of the safety of medical devices, the issuance of import and export licenses for narcotic substances and the supervision of vital drugs and their prices.
The Federal Service for the Supervision with Regard to Consumer Rights Protection and the Protection of Human Wellbeing (Rospotrebnadzor) is the Russian supervisory authority for consumer protection and health protection. It reports to the Ministry of Health and Social Development. This Federal Service is responsible for hygienic-epidemiological issues, toxicological, hygienic and other evaluations as well as the development and implementation of laboratory work, accreditation and standardization.
In this context, the research institute of the Russian Academy of Medical Sciences (RAMS) is also worth mentioning. This scientific institute has its own research laboratories and an affiliated hospital. The RAMS primarily focuses on physical-biochemical research. In this area, the institute deals with risk assessments regarding nutrition issues and issues of consumer health protection, among other things.
Founded in 1927, the Food and Drug Administration (FDA) is maybe one of the best known and oldest drug authorities. Subordinate to the Ministry of Health, the FDA is responsible for ensuring the quality, effectiveness and harmlessness of human and veterinary drugs, biological products and medical devices. The safety of foods and cosmetics is also among its responsibilities.
Since it is the duty of the FDA to protect public health in the USA, its area of responsibility comprises a wide range of products. The FDA also monitors the production, marketing and distribution of tobacco products, for example. However, electronic devices emitting radiation are also strictly regulated by the FDA. This includes microwaves, ultrasound scanners and X-ray apparatuses.
Despite its comprehensive responsibilities, the FDA is primarily responsible for quality assurance in the pharmaceutical industry, as the USA is the largest pharmaceutical market in the world. The FDA introduced the term “Good Manufacturing Practice” in 1962 with the “Current Good Manufacturing Practice Initiative” (cGMP). This initiative established essential guidelines for the production, processing and packaging of pharmaceutical products.
Your competent partner for specialist pharmaceutical translations
AP Fachübersetzungen specializes in translation and interpreting services for the pharmaceutical industry. With us, you will always receive high-quality and professional translations that are easily understood by both doctors and pharmacy technicians - regardless of whether the translation is from or into German.
Do you have any questions or would you like to directly commission a translation or an interpreting job? Feel free to contact us!