When opening up new markets, there is no way around GMP inspections in the pharmaceutical sector. Passing foreign GMP inspections requires thorough preparation. This also includes the selection of a specialized interpreter. Read more to find out how the qualifications of a pharmaceutical interpreter can be verified.

In 2020, Germany had the fourth-largest market share in the pharmaceutical industry and thus, as in previous years, occupied one of the leading positions worldwide, with only 3 countries ahead of Germany in this respect: the USA, China and Japan. In addition, Germany is the largest exporter of chemical-pharmaceutical products, as German pharmaceutical companies ensure that there is a stable export surplus. German medicinal products, medical devices and cosmetic products, and food supplements are very popular abroad due to their excellent quality and enjoy a very good reputation, not least in Eastern European countries. The CIS and EAEU countries, and Russia in particular, are among the largest buyers of medicinal products among non-EU countries.

Large number of GMP inspections in Germany by foreign authorities

Due to active exports, the number of foreign GMP inspections being carried out at German pharmaceutical companies is increasing to ensure compliance with the GMP (Good Manufacturing Practice) requirements of the respective countries to which the German chemical and pharmaceutical products are later to be imported. GMP inspections are carried out by the GMP inspectors of the competent foreign authorities.

Although many of the foreign GMP inspectors are proficient in English, communication is usually preferred in German and in the GMP inspectors' native language so that questions and answers can be formulated as precisely as possible. Professional pharmaceutical interpreters and GMP translators ensure a complete, fluent and technically correct translation of what is said into the other language.

What to consider for GMP inspections by foreign authorities

Apart from the linguistic factors and language barriers, the varied professional experience of the GMP inspectors and regulations of the foreign authorities with regard to the GMP inspection process are important. For example, the focus of Russian GMP inspectors usually differs from that of FDA inspectors . Some GMP inspectors also focus more or less intensively on certain aspects, either individually or based on current trends. Although there are only a few differences between the Russian and European GMP guidelines, how their meanings are interpreted can vary. Therefore, one should be aware of the potential differences. Our professional pharmaceutical interpreters will ensure that this information, among others, is addressed. Our interpreters have already completed numerous GMP inspections and can provide detailed advice on what to look out for in the run-up to a GMP inspection. Our pharmaceutical interpreters are already familiar with some GMP inspectors and their approaches from previous GMP inspections. In addition, our experienced translators and pharmaceutical interpreters have a clear idea of the procedure for upcoming GMP inspections and are familiar with the specialist pharmaceutical terminology in the documents that are usually required. Pharmaceutical terminology has its own separate blog post.

Finding the right pharmaceutical interpreters for your GMP inspection

The selection of qualified interpreters has a significant influence on the success of a foreign GMP inspection. The selection and qualification of suppliers and service providers is a multi-stage process. Although there are no strict or regulatory requirements with regard to the selection of interpreters, a number of things should be taken into account before commissioning them. Interpreting is not a regulated profession in Germany, so anyone can call themselves an interpreter for any language. However, this makes the search for an interpreter all the more complicated because the risk of employing unqualified individuals increases with a larger number of interpreters.

Here are some recommendations on how to find the most suitable, pharmaceutically specialized interpreter for your foreign GMP inspection. Pharmaceutical manufacturers should ask potential interpreters to about their qualifications and relevant experience. This can be, for example, a university diploma or a certificate of completion of a specialized academic education. As no institution in Germany offers interpreter studies or training with a focus on pharmacy, it is advisable to check whether the potential interpreter has any other experience in the pharmaceutical or GMP sector. This could be freelance work or a permanent position in a translation agency specializing in pharmaceuticals. In addition, experienced pharmaceutical interpreters can usually provide a few letters of recommendation from their clients, who - without disclosing any confidential information - can use them to prove their experience in the pharmaceutical sector. Such letters of recommendation or references usually also contain the contact details of the respective pharmaceutical companies so that the information they contain can be independently verified.

Our practice as pharmaceutical interpreters for GMP inspections

At GMP-inspection.com, we know from experience that not every interpreter with a university degree or vocational school qualification can do justice to the task of interpreting complex pharmaceutical and procedural content. When choosing the right language service provider, clients should place particular emphasis on interpreters' experience in the pharmaceutical sector, which ideally can also be confirmed. The fact that there are only a few interpreters in Germany who specialize in GMP inspections can make the search difficult at first glance. However, the interpreters with numerous letters of recommendation from pharmaceutical companies and long-standing satisfied customers stand out from the rest.

Most of the translators and interpreters in our team already have relevant experience in the pharmaceutical sector. Other new interpreter colleagues spend months building up the necessary knowledge in this field. To do so, we read pharmaceutical literature, create glossaries with pharmaceutical vocabulary and constantly maintain and expand these. We also attend GMP conference and other training events. After consultation with the inspected pharmaceutical company, new team members even accompany us during GMP inspections at the beginning to familiarize themselves with the special procedures involved. In this way, we are able to ensure that only certified and specialized interpreters and translators are used for the GMP inspections we supervise.

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