Linguistic Support for GMP Audits

The auditing of a company’s proprietary pharmaceutical production facilities, as well as partner facilities that manufacture active pharmaceutical ingredients and finished pharmaceutical products, for compliance with good manufacturing practices (GMP) is one of the most pressing issues facing the pharmaceutical industry today. For the past several years, it is an issue that has also kept translation agencies busy, since interpreting is one of the most requested services during GMP audits.
Pharmaceutical companies are constantly on the lookout for vendors who can provide such services. They normally find interpreters using one of two methods: either they hire a specialist after an independent search, or they approach a translation agency for help. Companies who favor the second route should take the following details into account when choosing a partner, especially if they are considering a long-term partnership:

• The agency’s expertise and experience in life sciences;
• The range of services offered: for example, linguistic support for GMP audits may include the actual interpreting, transportation and accommodation for the interpreter, and translation of the site master file (SMF) and post-audit report;
• The agency’s ability to provide an interpreter at the audit location or an interpreter for a rare language;
• The ability to hire a specific interpreter the client wants on their project;
• The payment terms: the company provides the option of paying for services later based on a pre-approved payment deferral.

Regardless of these details, the interpreter is still the most important element. This is why a well-selected vendor with good references, knowledge of specific terms and experience of cooperating with auditors can provide audit support to a high standard and help accomplish the primary objective: obtaining a GMP certificate.