Interpreting at GLP, GCP, GMP inspections and audits
When it comes to such responsible tasks as, for example, the inspection of pharmaceutical companies by foreign authorities regarding compliance with the rules of Good Manufacturing, Clinical or Laboratory Practice, interpreters who are specialized in the field of pharmacy and experienced in GMP, GCP and GLP inspections are commissioned.
At GMP inspections, conscientious interpreters feel the responsibility that the result of the entire inspection largely depends on the quality of their work. This fact always puts a certain amount of psychological pressure on the interpreters. Therefore, it is all the more important to take the utmost care when searching qualified interpreters for upcoming GMP inspections.
What are GMP, GCP, GLP inspections and audits?
GMP is the abbreviation of Good Manufacturing Practice. The quality of the production processes and the production environment when manufacturing medicines and active substances must be ensured. To guarantee quality assurance, GMP guidelines are followed. In pharmaceutical companies, GMP inspections regularly take place.
GCP means Good Clinical Practice. When conducting clinical studies or trials with medicines on humans, the rights, safety and well-being of the participants must be paramount. To ensure this, GCP inspections and audits are regularly carried out in this area.
A GLP inspection ensures Good Laboratory Practice. When such an inspection is carried out by foreign authorities with regard to compliance with the rules of Good Manufacturing, Clinical or Laboratory Practice, an interpreter specialized in the field of pharmacy and experienced in GMP, GCP and GLP inspections has to be commissioned.
How does interpreting during inspections and audits work?
GMP, GCP and GLP inspections often require simultaneous interpreting. This means that what is said is translated from the source language into the target language in real time. Therefore, foreign authorities understand basically every word without delay. The language mediator translates extremely complex content quickly and accurately. One interpreter is assigned to one inspector or even several inspectors at a time.
What are the challenges of interpreting at inspections and audits?
A GMP interpreter has skills which far exceed classic interpreting. The special terminology and the necessity to work in a highly concentrated manner for 8 to 10 hours and keep changing from one language into another (and sometimes even into a third language) need to be considered in particular here. The experts dealing with GLP, GCP and GMP inspections know what large volumes of information the interpreters have to process. Nevertheless, they are expected to interpret very complex content quickly and accurately. Quite often, simultaneous interpreting is required, which not every linguist is able to do.
To guarantee the simultaneous interpreter’s high level of concentration and efficiency, it is recommended to use two linguists taking turns every half hour. However, taking turns is not always possible in practice since one interpreter is assigned to one inspector or even more inspectors. The volume of information is always very large. The interpreter has to be extremely resilient and willing to interpret for several hours without a break.
The information portal GMP News has discussed the difficulties and challenges of interpreting at GMP inspections in an interview with our Managing Director – Alexander Podarewski, sworn translator and interpreter for the Russian language in Germany – and has asked him a few questions about the particularities of interpreting jobs during GMP inspections in Germany.
Why is it important to commission a professional interpreter?
Interpreting at GMP / GCP / GLP inspections and audits is one of the most complex forms of language mediation. It is therefore particularly important to hire an experienced, conscientious and stress-resistant interpreter. The language experts at AP Fachübersetzungen are multilingual professionals with many years of experience, specializing in the field of pharmacy. Our interpreters know how important a good translation is during GMP inspections and that the result of the inspection largely depends on the quality of their work.
In order to obtain a GMP certification from foreign authorities, it is necessary to commission a certified interpreter. This is the only way to ensure the success of an inspection. Our language professionals translate mainly into their own native language, making the translation sound particularly authentic. In addition, our language mediators are proficient in all interpreting techniques and very familiar with pharmaceutical translations. A specialist interpreter not only transfers information correctly into the target language, but is also familiar with scientific connections in the development and manufacture of medicines and medicinal products as well as their effects.
Pharmaceutical interpreting services cover the fields of medicine, technology, biology, microbiology and chemistry. In addition to that, a specialist interpreter in this filed also has to be thoroughly familiar with the area of production, storage and logistics. In some cases, the language expert also needs to be familiar with the field of law. Contact AP Fachübersetzungen to completely avoid misunderstandings und ambiguities during your GMP inspection. We guarantee impeccable specialist quality and only employ highly competent, conscientious and resilient specialist interpreters.