As professional GMP translators and pharmaceutical interpreters, we explain below how a bundle of documents requested shortly before a GMP inspection can be translated in a manner that is prompt, in compliance with the specialist terminology, and cost-effective.

For many Austrian, Swiss and German pharmaceutical manufacturers, the documents and SOPs are often only available in German - professional GMP translators are needed here

Although it is now common practice for many pharmaceutical manufacturers to use English as the language of communication, many documents are still written in the respective national language. Therefore, professional pharmaceutical translations are the method of choice in such cases to ensure that the commissioned GMP inspectors understand the processes of the inspected pharmaceutical manufacturer. Professional pharmaceutical translations of German documents (in the case of Germany, Austria and Switzerland) into Russian enable the documents to be checked by the Russian authority SID & GP. Some of the Russian GMP inspectors are also proficient in English. For this reason, permission is repeatedly granted for translations to be made into English instead of Russian. However, this must not be assumed tacitly, but is always agreed in advance with the authority.

Professional pharmaceutical translations of 500 - 1,500 pages of documents shortly before the start of the remote GMP inspection - How many translators do I actually need?

Since the beginning of the coronavirus pandemic, GMP inspections of foreign pharmaceutical manufacturers have taken place almost exclusively in remote mode using appropriate telecommunications solutions. Only since November 2022 have GMP inspectors occasionally traveled in person again to inspect the respective pharmaceutical manufacturer on site. In the run-up to the remote GMP inspections, the inspecting authority requests professional pharmaceutical translations of numerous documents, SOPs, work instructions, job descriptions, etc., while GMP translators or pharmaceutical interpreters are not permanently used during the actual GMP inspection, but only at the beginning and for the final meeting. In between, the Russian GMP inspectors like to study the documents of the inspected pharmaceutical manufacturer on their own. It has become common practice among the employees of the inspected pharmaceutical companies to unofficially call such a GMP inspection a document inspection.

For example, the Russian GMP inspectors send the GMP inspection agenda ten calendar days before the start of the inspection. This is an extremely short period of time to translate 500 - 1,500 pages of complex texts professionally and taking into account specific technical terminology. Of course, it cannot be ruled out that fewer than 500 pages may need to be translated. Nevertheless, our company GMP-inspection.com from Nuremberg has found that even more than 1,500 pages need to be translated, especially if the product is intended for the Russian Federation or the EAEU market or if the distribution of this product is particularly important for the pharmaceutical manufacturer in these markets. A good translator (whether specialized in pharmaceuticals or other fields) translates between seven and eleven standard pages per working day, i.e. nine pages on average. A standard page consists of 30 lines of 52 characters each, including spaces. A standard page therefore consists of 1,560 characters.

Ten calendar days before the remote GMP inspection include at least one weekend, leaving a maximum of eight working days for translation. If we assume 500 pages and divide this figure by nine standard pages and eight days, we arrive at a value of 6.94. This means that seven translators are required for 500 pages, who must of course have a specialization in the pharmaceutical sector. In the case of freelancers, it must first be clarified whether the translator has the capacity to produce the translation. If there are 1,500 pages of texts to be translated, the number of translators that a manufacturer needs for the professional pharmaceutical translation of its texts just before the GMP inspection triples accordingly.

Order 21 translators ten calendar days before the remote GMP inspection?

This is the task the inspected pharmaceutical manufacturer has to solve when it has to have around 1,500 pages of text translated from its documents or SOPs ten calendar days before the GMP inspection in order to "make the GMP inspectors happy".

Some people now rely on machine translators in their everyday lives. However, machine translators are not yet good enough in terms of quality to carry out such important translations of your own pharmaceutical documents, on which the results of your company's activities may depend for several years or even its economic survival. The quality and reliability of machine translations are not yet mature enough for this.

And we haven't even touched on the issue of data security yet. Nobody wants to upload confidential company documents to distant or possibly completely unknown servers or entrust them to a technology that cannot be controlled.

How easy is it to sign a non-disclosure agreement (NDA) with 21 specialized GMP translators within ten calendar days before the Russian remote GMP inspection? Before asking this question, it is first necessary to check whether there are so many available GMP translators or pharmaceutical interpreters on the market. Once you have found enough translators with pharmaceutical and GMP specialization, it will also take some time to sign the non-disclosure agreements, because not every translator will sign the documents presented to them immediately, but some topics must first be clarified and adapted in the non-disclosure agreement.

Unfortunately, it also happens that underutilized translators claim that they have expert knowledge in this or that area, which is unfortunately not the case in practice. One or two pharmaceutical companies have already been bitterly burned - with fatal results for their own GMP inspections. Expert knowledge should always be verifiable, be it through confirmations, references or letters of recommendation from existing customers, publications in the trade press, verifiable customer testimonials on well-known portals or other verifiable and concrete information.

What is the best solution? Hire a translation agency that specializes exclusively in pharmaceutical translations and interpreting during GMP inspections. However, you should not only use such service providers ten calendar days before the start of your GMP inspection, but should announce the inspection as far in advance as possible, as real experts are often in high demand and therefore very busy. We have been on the market with GMP-inspection.com and our founding company AP Fachübersetzungen since 2010 and know how to translate 1,500 pages and more in the shortest possible time professionally and in compliance with GMP-specific terminology - whether into English or Russian.

What distinguishes the GMP translators and pharmaceutical interpreters at GMP-inspection.com?

Thanks to our many years of experience in the industry, we have already translated more than 100,000 pages of documents from the pharmaceutical sector and the related fields of medicine and technology for our customers. Because we use state-of-the-art technology to manage our translations in special databases, we are able to achieve completely different translation speeds that are many times faster than those usually achieved by non-specialized translators.

This experience is also reflected in our pharmaceutical interpreters for GMP inspections and our experts for professional pharmaceutical translations. As they are familiar with the procedures of a GMP inspection, they are usually able to assess which topics will be discussed and when, and what the GMP inspectors are looking for. Our professional pharmaceutical translators and pharmaceutical interpreters already know many of the inspectors from previous on-site or remote GMP inspections. This creates additional trust. But even when dealing with unfamiliar inspectors, the right tone is ultimately important. A friendly, open-minded approach creates a pleasant and relaxed working atmosphere without distracting from the demanding work.

What do our professional GMP translators use to translate pharmaceutical documents much faster than our competitors?

Not every translator - regardless of the focus of their translation work - works with translation software (CAT tool) in the progressive 21st century. There may be various reasons for this. Translators who use such technologies have a terminology database (a kind of glossary) and a translation memory. The benefits of these technologies do not become apparent on the first day; the databases have to be "fed" over the years, i.e. terms and translation units are stored in these tools. As a GMP translator specializing in the pharmaceutical sector with many years of experience, we have been able to enter several thousand pharmaceutical translations into our translation database and build up a solid GMP glossary with over 6,000 technical terms and definitions. Thanks to the texts stored and constantly updated in the TM (translation memory), we can create pharmaceutical translations of new documents in pre-translated form within a few seconds, so that the human translator only has to confirm the segments that are automatically recognized as repetitions. A distinction is made between 100% matches, i.e. stored translation units that match the text to be translated in full, and so-called fuzzy matches, in which parts of the segment have already been translated but still need to be adapted by the human translator. Computer-aided translation with a CAT tool therefore saves a considerable amount of time when translating. We are happy to pass on the discounts for existing pharmaceutical translations to our customers, who benefit both from the considerably faster production of their translations and from lower costs. But above all, thanks to our valuable and long-standing experience as GMP translators and pharmaceutical interpreters, we are pleased to be able to contribute to the successful completion of our pharmaceutical clients' on-site and remote GMP inspections. Hire us for the linguistic support of your upcoming GMP inspection and you will never need other translators and interpreters again!