There is a widespread assumption that it is enough to be proficient in two languages in order to work as a qualified translator or interpreter. However, there is also the opposite view: without a professional qualification, it is not possible to interpret in the respective field. We explore this question in the GMP interpreter blog.

From an outside view the work of a qualified interpreter looks relatively simple: You hear something in one language, understand it and repeat it, but in a different language. In the case of everyday conversation and with excellent linguistic skills, this can certainly be the case. However, when it comes to demanding content in an area with extensive specialised terminology, non-professional interpreters quickly reach their limits. Qualified interpreters and GMP translators are therefore usually used, especially in complex fields like pharmaceuticals and GMP inspections or GMP audits.

Qualified translators have undergone a demanding training programme

To become a qualified translator or interpreter, it is not enough to speak one or more foreign languages. During their studies, prospective translators or interpreters are not only taught the rules of the respective language (e.g., Russian or English) but also the basics of linguistics and translation theory. Courses on the history and culture of the countries in which the foreign language is spoken are also part of their training. Qualified translators and professional interpreters are familiar with the methods and techniques of translation and interpreting (such as consecutive or simultaneous interpreting, including the use of complex note-taking techniques) and apply them skilfully in their work. As in any field, a talented self-taught interpreter can go a long way, but especially for sensitive tasks such as accompanying a GMP inspection or audit. Those responsible at pharmaceutical manufacturers understandably prefer to entrust these to qualified pharmaceutical interpreters, whose knowledge and skills in translation and interpreting can be objectively proven.

Furthermore, a qualified translator and professional interpreter is characterised not only by excellent foreign language skills, but also by a refined use of their own native language. This is because not all native speakers can express themselves appropriately in the respective situation and clearly formulate their thoughts, let alone the thoughts of another person. This is why studying to become a translator and interpreter also includes compulsory lessons in the native language.

GMP translators and pharmaceutical interpreters require comprehensive expertise and experience

However, some argue that only those who hold a degree in the relevant field should be permitted to translate and interpret specialised texts. According to this view, "general" translators and interpreters lack the in-depth expertise required to fully understand and accurately convey technical content.

There is a lot to be said in favour of this thesis: Experts are usually far more knowledgeable in their field than outsiders - which is only natural, otherwise they wouldn't be "experts". In addition, it is indeed essential not only to master the specialised terminology in two languages, but also to understand the interrelationships. Otherwise, misunderstandings with serious consequences can arise - in the pharmaceutical sector, for example, it is possible that a Russian GMP inspector misinterprets an interpretation from German and, as a result, the higher-level Russian authority SID&GP refuses to issue the necessary certificate. This is why it is always worthwhile for a GMP inspection or GMP audit to appoint one or more qualified translators and pharmaceutical interpreters who specialise in pharmaceuticals and GMP inspections or GMP audits. However, the word "specialised" does not mean that the interpreter has acquired specialist training in the pharmaceutical sector, but rather that he or she has many years of experience in this field and knows exactly what needs to be taken into account when interpreting during a GMP inspection. But even a recent graduate of a degree programme in translation studies or conference interpreting can perform very well after thorough preparation. If you want to make it as a pharmaceutical interpreter for GMP inspections or translator of pharmaceutical documents, you have to deal intensively with the demanding subject matter, acquire pharmaceutical knowledge in various ways and continue to develop this knowledge within the framework of suitable further training. This is the only way to be recognised as a qualified translator for GMP & the pharma industry - even without a degree in pharmacy.

Conclusion: Complex topics require qualified translators and professional interpreters

Our recommendation is clear: A verifiably qualified translator or interpreter (i.e. with a translation degree and specialisation in pharmaceuticals and GMP in professional life) is the perfect solution if you are facing a GMP inspection by the Russian SID&GP or the American FDA. This ensures smooth communication between the GMP inspectors and the employees at the inspected German, Austrian or Swiss site. Our qualified translators and interpreters are language masters with extensive expertise in the field of pharmaceuticals and GMP.

Image: GMP-inspection.com