Drugs were already used in prehistoric times. Find out more about the origins of pharmacy, its historical development and the nature of pharmacy in modern times! In our blog post, we also report on the importance of GMP in pharmaceutical manufacturing.

Like many other technical terms, the word "pharmacy" comes from the Greek. It is derived from the word φάρμακον, which means "remedy", "poison" or "magic". Pharmacy is the science of the development, manufacture, quality assurance, efficacy, safety, use and storage of drugs. As a complex and interdisciplinary field, pharmacy applies knowledge from chemistry, biology, medicine and other natural sciences. It is therefore no wonder that pharmacists have to undergo a difficult and lengthy training programme.

Origins of pharmacy

Finds from prehistoric times already prove the use of drugs. Pharmacological knowledge from the advanced civilisations of Mesopotamia and Egypt has been preserved on clay tablets and papyri. Over time, the Greeks in the Byzantine Empire and Arab physicians from the Orient also contributed to the development and growth of knowledge in this science. However, modern pharmacy was only recognised as a discipline in its own right from the 17th to 18th century.

For a long time in the Middle Ages, only educated monks and nuns were involved in the production of remedies and the treatment of illnesses. It was not until the 12th century that the shops dealing in spices and medicinal herbs in southern Italy became the first modern pharmacies. Emperor Frederick II. (1194-1250) passed the first code of law, the Liber Augustalis, in which pharmacy was explicitly mentioned for the first time. In the so-called Edict of Salerno, he ordered the separation of the medical and pharmacy professions for the first time. The first public document on German soil to mention pharmacies is the Nuremberg Pharmacy Oath (1338/1360), which states that

"every apothecary [shall] swear that he will prepare for the poor and the rich, without endangering them, in every case what has been ordered orally or written down. Let him take such remuneration for his work that he has a modest profit for his food and labour according to his conscience."

Pharmacies were probably only located in large commercial centres such as Mainz, Cologne, Basel and Heidelberg in the past. It was only over the next 200 years that the pharmacy established itself as an important part of the public healthcare system. By the 17th century, the number of pharmacies was growing rapidly and the profession of pharmacist was gaining authority in society.

Pharmaceutical nature in modern times

The Swiss physician Theophrastus Bombastus von Hohenheim, alias Paracelsus, revolutionised the pharmaceutical industry in the form in which it had existed for 2000 years and can still be traced back to the methods of antiquity. In the 16th century, he developed a new approach to the production of drugs: In addition to conventional production from individual natural substances, Paracelsus brought new so-called "chemiatric" remedies onto the market. Since then, the production of drugs has become increasingly complex and now also includes chemically produced active ingredients. From the 19th century onwards, medicines could no longer just be produced in a normal pharmacy, so the production of medicines was spun off from the pharmacy trade and developed into an independent industry - the pharmaceutical industry.

Regulation of pharmacist training

In the past, the professional qualification of a pharmacist was still acquired in private institutions, whereby training was only regulated to a limited extent by the state or other institutions. As the complexity of the profession continued to grow, the demands on pharmacists became increasingly stringent. Nowadays, a university degree is required to work in the pharmaceutical industry.

Our focus at GMP-inspection.com is on pharmaceutical translations and interpreting services. We offer pharmaceutical translations and interpreting for the following areas, among others:

• Accreditation
• Audits and GMP inspections by foreign regulatory and supervisory authorities
• Manufacture of drugs and active ingredients
• Operating instructions for equipment used in pharmaceutical production
• Documentation in the areas of quality assurance and quality control
• Results of device calibrations
• Vaccine and active ingredient design
• Guidelines and directives
• Manufacturing authorisation
• Air conditioning, cooling and analysis technology in pharmaceutical laboratories
• Temperature-controlled storage and logistics
• Qualification of clean rooms and systems
• Microbiological tests
• Package inserts
• Staff training
• Sampling plans
• Production processes
• Testing of air and water treatment systems
• Pest control
• Training documents
• Standard operating procedures (SOPs)
• Study and inspection reports
• Validation results
• Regulations on disinfection, personal hygiene and storage.

Specialist areas of pharmacy

We also offer specialised technical translation and interpreting services for various sub-fields of pharmacy, including:

• Biopharmacy
• Clinical bharmacy
• Pharmacology
• Pharmacoepidemiology
• Pharmacoeconomics
• Pharmaceutical biology
• Pharmaceutical biotechnology
• Pharmaceutical chemistry
• Pharmaceutical bechnology
• Toxicology

What pharmaceutical translations are all about

If you want to work as a translator or interpreter in the pharmaceutical field, you have to be prepared for the fact that pharmacy is a comprehensive scientific field that includes natural sciences such as microbiology, physics and chemistry, as well as technology, logistics and even law to some extent. In order to be able to correctly translate complex pharmaceutical texts from one language into another, the pharmaceutical interpreter or translator must understand the entire life cycle of a drug, from development to clinical trials, through production at the site to market release. He must be well versed in production and logistics processes and in the functions of various systems. This is the only way to ensure smooth communication when interpreting.

The core issues of pharmacy include the questions of how additives and active pharmaceutical ingredients and ultimately medicinal products are produced, how they can be used and what effects they have. As research results in these fields appear in international medical journals, there is often a great need for impeccable pharmaceutical translations. Professional pharmaceutical translators must pay particular attention to the correctness of specialised terminology and must not allow any errors in meaning, as a small misplaced word can have serious consequences. At GMP‑inspection.com, we have set up our own quality control system to ensure the highest quality and accuracy of our translations. Our pharmaceutical translators are not only proven language experts in their working languages, but also have strong expertise in the fields of pharmaceuticals and GMP. In accordance with the dual control principle, translations are proofread by a native speaker after completion to ensure that the text is technically and linguistically flawless.

Importance of GMP

The abbreviation GMP stands for Good Manufacturing Practice. Behind this is a quality management system that is characterised by standard operating procedures (SOPs) at all stages of pharmaceutical production.

Of course, medicinal products must be of high quality, safe and tolerable for the consumer. Therefore, certain quality requirements must be met during production, processing, packaging and storage to ensure that the products meet the stipulated standards. The system for ensuring quality in accordance with the GMP guidelines includes various aspects, including the management of documents, deviations, changes and risks, the qualification of equipment, the validation of processes and methods, the training of employees and the performance of audits. To ensure an effective, safe and high-quality end product, it is necessary to carefully document and check all processes. A pharmaceutical translator's challenge is to understand the meaning of all the steps in the process. He must have a comprehensive understanding of the processes in order to convey specialised information professionally and accurately.

In addition, the GMP guidelines regulate various processes, including complex water treatment, air purification, microbiological testing procedures, filling, packaging, storage and transport of medicinal products, sampling, hygiene and the operation and maintenance of various laboratory and production facilities.

GMP inspections include not only individual devices and machines, but also complete production lines used in the manufacture of active ingredients and medicinal products. Precise and trouble-free technology plays a crucial role in the pharmaceutical industry, as errors must be avoided in the development and production of drugs. Fully automated production systems are therefore usually used to carry out the individual production steps. The use of state-of-the-art production facilities minimises the risk of contamination caused by human error. However, specially trained employees are required to ensure the smooth operation and maintenance of these complex machines. They complete various training courses to acquire the necessary qualifications for operating the production facilities.

The expertise of an experienced specialist translator is required to ensure the flawless translation of complex procedures, processes and controls in the pharmaceutical sector. At GMP-inspection.com, we only use translators and interpreters who specialise in the pharmaceutical industry and the GMP sector and who have in-depth background knowledge and many years of experience in the industry. This helps to avoid misunderstandings and ambiguities and ensures that the translation is of the highest professional quality.

Authorisation and supervisory authorities

The authorisation procedure for medicinal products can vary from country to country. We have summarised some information for a number of countries below.

Germany

The German Medicinal Products Act (AMG) and the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) regulate the production of pharmaceuticals in Germany.

Monitoring the manufacture of medicinal products and ongoing clinical trials in the Federal Republic of Germany is the responsibility of a group of authorities that work together in the Central Agency of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG). The ZLG coordinates the federal states in the area of human and veterinary medicinal products and is responsible for various tasks, such as quality assurance in the monitoring and testing of medicinal products, the monitoring of online trade in pharmaceuticals and the recognition requirements and procedures for laboratories and certification bodies in the pharmaceutical sector.

Various higher federal authorities assume central tasks in the area of health monitoring. The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the authorisation and monitoring of medicinal products, the risk assessment and ‑registration of medical devices and the control of narcotics and precursors traffic. The BfArM is also involved in scientific research in the pharmaceutical sector.

Also worth mentioning is the Paul Ehrlich Institute, a federal institute for vaccines and biomedical drugs that reports to the Federal Ministry of Health. Its activities include the authorisation of vaccines and biomedical medicinal products, the approval of clinical trials, the testing and release of batches and the recording and evaluation of side effects. The institute also conducts applied research.

Strict quality controls by the regulatory authorities in the pharmaceutical industry ensure that only products of the highest quality that fulfil all requirements are released for the market.

European Union

The EU GMP guidelines set out guidelines for the GMP-compliant manufacture of medicinal products in EU countries.

While the European Commission is responsible for granting marketing authorisations for medicinal products, the scientific evaluation, monitoring and safety control of medicinal products within the EU is the responsibility of the European Medicines Agency (EMA). The European Directorate for the Quality of Medicines (EDQM), which reports to the Council of Europe, is also active in the field of pharmacy. It is responsible for compiling and continuously updating the European Pharmacopoeia and for the quality control of substances used in the manufacture of medicinal products by its own laboratories.

Russia

The Federal Health Protection Monitoring Service (Roszdravnadzor) is a health protection monitoring authority under the Russian Ministry of Health. Their responsibilities cover a wide range of tasks, including conducting inspections and audits to monitor quality and safety in medicine, licensing medicines and medical devices, inspecting healthcare facilities, pricing medicines, implementing government programmes to modernise the healthcare system, registering and monitoring the safety of medical devices, issuing import and export licences for narcotics, and monitoring vital and essential medicines and their prices.

The State Institute for Medicines and Good Practice (SID&GP) is responsible for carrying out GMP inspections of pharmaceutical manufacturers. The Russian GMP inspectors check the production processes through personal inspections of the sites or video tours and verify the correctness and traceability of the documentation. After passing the GMP inspection, the GMP certificate is issued to the inspected pharmaceutical manufacturer by the Ministry of Industry and Trade (Minpromtorg), to which the aforementioned SID&GP institute is directly subordinate, and market authorisation is thus granted.

The Federal Service for Supervision in the Sphere of Consumer Protection and Protection of Human Welfare (Rospotrebnadzor) is the Russian supervisory authority responsible for consumer and health protection. It is subordinate to the Ministry of Health and has various tasks, including carrying out hygiene-epidemiological investigations, toxicological assessments and the development and implementation of laboratory work, accreditation and standardisation.

Another institute active in the pharmaceutical sector is the RAMN, the Research Institute of the Russian Academy of Medical Sciences. As a scientific institution, it has its own research laboratories and an affiliated clinic. It concentrates mainly on physical-biochemical investigations and in this area deals with the assessment of risks in relation to nutritional issues and consumer health protection issues.

USA

Founded in 1927, the Food and Drug Administration (FDA) is the US regulatory authority for the quality, efficacy and safety of human and veterinary drugs, biological products and medical devices. Its main task is to protect public health, which is why the FDA is also responsible for controlling the production and distribution of food, cosmetics and tobacco products.

As the competent authority in the US market, which generates the highest sales worldwide, the FDA monitors quality assurance in the pharmaceutical industry. In the early 1960s, the FDA proposed the term "current Good Manufacturing Practice" (cGMP) for the basic rules governing the production, processing and packaging of drugs.

The perfect solution for your pharmaceutical translation

At GMP-inspection.com, we offer professional translation and interpreting services specifically for the pharmaceutical sector. We always deliver professional pharmaceutical translations, regardless of whether the translation is from German or into German.

Feel free to contact us if you have any questions or require a translation or interpreting service. We are here for you at any time!

 

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