Life sciences and biotechnology companies, such as the pharmaceutical industry, clinical research organizations, medical device and diagnostics manufacturers, use translation services strategically to expand into global markets. Before launching products internationally, they need to translate important documents to meet international standards, a process that can directly affect time to market. Although sometimes overlooked, translation is typically the last step in a development cycle that lasts years, just before submitting to regulatory authorities or using them on the factory floor. Translation costs between 0.01% and 0.1% of the pipeline cost. However, it can delay an investment, at a cost of ten to one hundred thousand dollars per day, depending on the product’s lifetime value, due to delays in launches.
Regulatory agencies in Latin America, such as ANVISA, COFEPRIS, and INVIMA, typically require pharmaceutical translations, such as clinical trials and informed consent forms, medical device translations, and others to be submitted in the native languages (Portuguese or Spanish). Similarly, GMP (Good Manufacturing Practices) translation is required for specific documents, but not for all, as local requirements vary by country. Still, it is best that the documents that operators must follow on the factory floor (SOPs – Standard Operating Procedures, batch results, etc.) be in the local language for better understanding and even for safety at work.
During global expansion, regulatory affairs managers, quality control directors, labeling leaders, and supplier managers need accurate GMP documents and, consequently, GMP translation services to ensure timely market entry. Small translation errors and even delays have a disproportionate impact on the success of expansion plans. The same applies to biotechnology translations, medical device translations, and regulatory translations in general. These errors or oversights can delay approvals by days or even weeks, compromising the outcome.
Why Accurate GMP Translation Services Matter
WLet’s explore the common pitfalls of Good Manufacturing Practices translation and how to avoid them. But first, what exactly are GMP and why are they necessary?
GMP defines the quality and safety standards that pharmaceutical and medical device companies must follow. Risks are generated during production: product quality issues, lack of batch consistency, or worker safety risks. GMP is designed to minimize them.
However, a poorly done translation can reintroduce risks, including in the relationship with regulatory agencies. The use of professional GMP translation services is essential to maintain compliance with agencies such as ANVISA, COFEPRIS, and INVIMA, as well as many other local authorities, and to keep global operations running smoothly.
Typical GMP Documents for Translation
When managing GMP translations, companies typically focus on a core set of documents that are essential for maintaining compliance and quality worldwide.
- Standard Operating Procedures: SOPs form the backbone of daily manufacturing activities, aiming to prevent problems that would disrupt the processes followed by the factory.
- Batch Results: They record all results and Certificates of Analysis during the manufacture of a given batch. They include sampling and quality control results (e.g., chromatography). If batch results are not accurately translated and well presented, this can lead to misunderstandings, delays, or regulatory rejection.
- Validation reports: These demonstrate that equipment and processes meet regulatory standards. Clear translations promote smooth regulatory audits and assessments, which helps speed up approvals.
Top 4 GMP Translation Pitfalls (And How to Avoid Them)
MMany companies, for different and sometimes unexpected reasons, fall into the same traps when translating GMP documents. Here are four of the most common ones (and how to avoid them):
- A single translator: No matter how skilled a person may be, GMP content needs multiple layers of review. Translation, as in other areas, is a team effort. It is essential to have a project manager with experienced translators, reviewers, and proofreaders. Documents such as batch results, which may contain handwriting and charts, will need a desktop publishing specialist (DTP) to reconstruct the scanned, flat PDF.
- Machine translation (MT) alone: MT can offer speed and cost savings, but it still cannot be used alone for regulatory content. MT alone multiplies the risk of errors by a factor of 10 to 20 compared to a single review step (our recent measurement in a test with a relevant sample). That is why it is important to have human experts review your GMP translations, and we always recommend 2 steps.
- Ignoring quality checks: Under deadline pressure, one may be tempted to skip quality control checks. It is a saving that generates other costs. Quality Control is now more–not less–critical. It is extremely important to follow a defined and traceable QC process, including checking the PDF file converted to Word format, to give one example.
- Uncontrolled terminology: A well-made glossary, preferably validated by the client, is still key to avoiding problems with regulatory agencies, which may flag the issue and delay approval. In addition, factory operators may be confused by the use of different terms for the same thing. We use translation memories, which can be integrated with MT and with the good old glossaries to keep the language consistent.
By avoiding these pitfalls, at a fraction of the cost of the pipeline, as we mentioned, companies can save time, reduce risks, and build trust with regulatory agencies. Translation, the final stage of documentation, deserves attention from those who want to globalize quickly and safely.
About Varendi
Varendi Translation helps the pharmaceutical, life sciences, and medical device industries avoid the common risks of translation services and get translations right the first time, ensuring faster approvals, smoother launches, and safer operations.
Founded in 1989 by three physicians and an engineer, Varendi combines technical expertise with cutting-edge technology to move your products forward quickly and safely. Dedicated multidisciplinary teams for short-term projects, quality control and traceability, up-to-date technology including translation memories, glossaries, and trained and secure MT, plus our excellent customer service ensure your translation is a success.
Contact Varendi today and let us help you accelerate the launch of your next product with confidence.
