BMR and BPR in the life sciences industry: why pharmaceutical translation goes beyond the “simple” translation of texts

Pharmaceutical translators do not only deal with “simple texts”. For drugs to go to market, instructions on the production and packaging of these medications need to be carefully prepared (and translated) in order to be compliant with the FDA and EMA GMP standards. Multiple factors come into play: language work aside, collaborative and efficient DTP teams and flawless QAs are a must in a cumbersome process where nothing can afford to go wrong.

Medical and life sciences translation services require precision and advanced technical knowledge, as the outcome of those texts significantly affects human health. Linguists have to be experts on the subject and able to guarantee quality when working to even the tightest deadlines and to adequately convey messages and instructions that have taken hours of research. Besides language skills, pharmaceutical translation requires multiple levels of quality control together with a deep understanding of the regulatory environment on an international level, as drugs can be produced in the EU to be marketed in the US or Asia and vice versa.

The drug production process requires an additional level of safety and rules to be followed. According to what is known as GMP compliance, all medicines marketed in the EU have to demonstrate observance of a certain minimum standard in their production processes. This standard is carefully monitored by the European Medicines Agency (EMA) through inspections in situ and with the coordination of GMP-related activities in the EU, one of which is the Quality Review of Documents (QRD), that helps to develop, review, and update templates used for product information for human medicines that are later translated and prepared for the different markets. According to GMP guidelines, medicines have to be of consistently high quality, need to be suitable for their intended use, and must comply with the requirements of the EU marketing or clinical trial authorisation from the manufacturing and documentation (with the subsequent multilingual versions) point of view. A similar process is harmonised overseas by the FDA, which verifies and approves translations that allow foreign drugs to be marketed in the US.

In order to meet the requirements of medicine production established by the EMA and the FDA, a series of documents have to be prepared by Regulatory Affairs departments and Clinical Research Organisations (and later translated and made compliant for their launch abroad), detailing the various production phases, procedures, and steps to be followed in the manufacturing of every batch of a medicine and in the pharmaceutical packaging and labelling. The Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) contain critical information for the production of drugs as well as the actual data of the processes carried out. They function as proof of the correct manufacture of the medicines, are checked by quality assurance teams and provide details such as time and responsible person for the activity explained, through the different stages of preparation. BMR, BPR, and the documentation designed to meet GMP and manufacturing guidelines do share similar aspects:

They share key information necessary for the pharmaceutical labelling, production, and packaging.
They are often created in a hybrid format, that combines printed and handwritten texts, cannot be edited straight away but need to be converted in editable files that keep the same information in the correct way.
They might have extra different requirements depending on the manufacturer and on their writing/equipment conventions, as different companies might use different IT systems or include different parameters that need to be respected aside from the FDA/EMA approval.

The translation and preparation of compliant files is for these reasons quite a laborious process as it involves a huge deal of manual work. Moreover, the staff generally dealing with the entire process are not solely devoted to it, but rather do it as just one part of their job. Both aspects make the full process extremely prone to errors. The nature of the work itself, requiring DTP, different layers of QA, and internal review, adds further possibilities for mistakes. After the documentation has been prepared according to the pharmaceutical company criteria, it has to pass another check as it needs to obey the regulatory requirements and be validated by the responsible authority. For example, documents submitted to the US FDA for review should be in English and any translations of documents submitted should have the original local language copy of the document accompanied by an English translated version of the document, verified for accuracy, so it is necessary to follow a precise sequence.