- Audits & inspections by foreign licensing authorities
- Production of pharmaceuticals and agents
- Requirement specifications
- Manuals of machines in pharmaceutical production
- Documentation in the fields of quality management and quality check
- Calibration results of devices
- Vaccine and agent design
- Guidelines & directives
- Production permits
- Air-conditioning, cooling and analysis technology in pharmaceutical laboratories
- Temperature-regulated storage and logistics
- Qualification of clean rooms and systems
- Microbiological tests
- Package inserts
- Staff training
- Sampling plans
- Production processes
- Examinations of air and water treatment plants
- Pest control
- Training documents
- Standard operating procedures (SOPs)
- Study reports
- Validation results
- Regulations for disinfection, personnel hygiene, storage, channeling processes
We further offer specialist translation and interpreting services for the following pharmaceutical fields:
- Clinical pharmacy
- Pharmaceutical biology
- Pharmaceutical biotechnology
- Pharmaceutical chemistry
- Pharmaceutical technology
Particularities of pharmaceutical translations
Pharmacy deals with the development, production, quality management, effects, safety, use and storage of drugs, among other things. Therefore, pharmaceutical translations do not only comprise medicine and sciences such as biology, microbiology and chemistry but also technology, logistics and at times, even law. This makes pharmacy one of the most complex and comprehensive specialist fields in which only experienced translators and interpreters can and should translate texts and information correctly. 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 the production and logistics in order to understand and translate all processes of the production line from the function of small machines and water treatment units to storage management.
Raw materials, excipients and agents, their composition and their fields of application and effects are the pillars of pharmacy. Pharmaceutical companies, universities and supervisory authorities and many other organizations spend huge amounts of money exactly on this kind of research and the associated quality management and often publish their results internationally. In this case, a flawless technical translation 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 translation and the correct use and linguistic transfer of specialized terminology, we only employ highly competent specialist translators with many years of experience in the field of pharmacy. To guarantee the specialist and linguistic accuracy, a native-speaking expert always proofreads the translation – as per the saying “trust but verify”. When it comes to your translation, we take this to heart and do not take any risks – quite the contrary: we minimize all possible sources of risk or even neutralize them completely. With us, your specialist translation is in competent and experienced hands.
GMP & production lines
Good Manufacturing Practice (GMP) particularly includes guidelines for the quality management of the production processes and environment relevant for the production of pharmaceuticals and agents and the associated quality management.
The highest priority is of course to ensure the quality, harmlessness and tolerance of a drug for the consumer. This is why mandatory quality requirements during production, processing, packing and storage must be adhered to. The GMP-compliant quality management system includes document, deviation, change and risk management, the qualification of the equipment, the validation of processes and methods, staff training and audits. Any and all processes have to be documented and scrutinized with meticulous precision in order to deliver an effective, risk-free and high-quality end product. The translator or interpreter has 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 translate the contents in this field.
The GMP guidelines also regulate complex water treatment processes, air purification, microbiological test methods, the bottling, packing, storage and transport of drugs, sampling, hygiene and the operation and maintenance of miscellaneous equipment in the laboratory or production line.
In a GMP inspection, individual equipment, machines and plants are scrutinized as well as entire production lines for the production of agents and pharmaceuticals. In the pharmaceutical industry, an important factor during production is precise technology as mistakes in the development and production of pharmaceuticals are extremely unwelcome. For this reason, production lines, which are completely automated production systems for processing production steps, are utilized. Thanks to these sophisticated plants, 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 the production plants and go through multiple training courses to achieve the required qualification.
Those 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 eliminate misunderstandings and ambiguities completely and to guarantee the flawless quality of the technical translation, we from AP Fachübersetzungen only work with extremely competent specialist translators and interpreters who have the vital 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 gathered some interesting facts about some of the many 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) and the German Ordinance for the Manufacture of Medicinal Products and Active Agents (Arzneimittel- und Wirkstoffherstellungsverordnung).
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) 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. Their range of responsibilities includes the quality management and the supervision and examination of drugs, e-commerce with pharmaceuticals as well as their advertisement, recognition 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) for example is responsible for the approval and supervision of pharmaceuticals, risk identification and risk assessment of medical products and the monitoring of 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 management 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 the GMP-compliant production of pharmaceuticals in the member states of the EU.
Approving drugs 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 pharmaceuticals 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 the preparation and the continuous development of the European pharmacopoeia and the quality management of the substances used in drugs; 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 inspection and supervision of the healthcare system. This authority is in charge of quality control and safety of medical practice which it ensures through inspections and audits, the circulation of drugs and medical devices, the inspection of healthcare facilities, drug pricing, the implementation of public programmes to modernize the health care system, the registration and monitoring of the safety of medical devices, the issue 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 which reports to the Ministry of Health and Social Development. This authority is responsible for hygienic-epidemiological issues, toxicologic, 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 establishment has its own research laboratories and an affiliated hospital. The RAMS majorly focuses on physical-biochemical research and deals with risk evaluations 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 most popular and oldest drug authorities. Subordinate to the Ministry of Health, it is the responsibility of the FDA to guarantee the quality, effectiveness and harmlessness of human and veterinary drugs, biological products and medical devices as well as the safety of foods and cosmetics.
Since it is the duty of the FDA to protect public health in the USA, its area of responsibilities comprises a wide range of products. It hence supervises for example the production, marketing and distribution of tobacco products. However, electronic devices emitting radiation are also strictly regulated by the FDA. This includes microwaves, ultrasonic units and x-ray machines.
Despite their numerous duties, the FDA is primarily responsible for the quality management as the USA is the strongest and most lucrative pharmaceutical market in the world. Thus, the FDA introduced the term “Good Manufacturing Practice” in 1962 with the “Good Manufacturing Practice Initiative” (GMP). This initiative regulates essential guidelines for the production, processing and packing of pharmaceutical products.