15.10.2019 | LOGFILE Feature 38/2019

Your question - Our answer

Is there a legal requirement for the document language of GMP-relevant documents?

Is there a legal requirement for the document language of GMP-relevant documents?

4 min. reading time | by Sabine Rabus

 

In our company it is planned to write all documents in English. However, many employees do not speak English. Is there a rule that says that the documents must be "readable and understandable" for employees?

We passed the question on to two GMP inspectors. Their comments read as follows:

"SOPs are primarily intended for the company and its employees and only subsequently for external parties such as customers, auditors and inspectors. SOPs must therefore be written in a way that employees can read and understand them. This applies not only to simple and understandable wording, but also to language.

This means that if the employees only speak their mother tongue and no English, then SOPs, etc. that are written exclusively in English will miss their goal and task as part of the QMS. For employees, documents that are incomprehensible to them have little or no significance.

In such a case, the company cannot prove a functioning quality management system (EU GMP Guide Chapter 1). The functionality is limited by the language barrier.

It is not for nothing that American companies for example, spend a lot of time and effort in assessments to test whether and how well new employees can read, understand and implement English. A compromise that I often see with contract manufacturers is bilingual documents, i.e. documents in "employee language" and in English.

Possible references in the EU GMP Guide:

  • Chapter 4, Documentation,  4.1: Complex systems need to be understood, ...
  • Chapter 4, Documentation,  4.4: The style and language of documents should fit with their intended use.

This view is supported in the second expert comment:

"As part of GMP inspections, we require that documents be written in a language that employees understand. It is about both the language style and the language itself. The type of language and style required depends on a number of factors, such as the official language, the mother tongue of the staff and/or the languages learnt by the staff. Regardless of the language chosen, it must be ensured that employees can understand the documents. Documents may need to be (partially) bilingual in certain regions, e.g. in parts of Switzerland, when implementing global (e.g. English) SOPs at the local (German-speaking) site, or when employing staff who do not understand the original document language.

As part of training (e.g. examination of training success) or self-inspections for example, it must be checked that the employees can adequately understand the documents.

If the documents of a company are prepared exclusively in one language because it is assumed that all employees speak this language, this must also be proven (if it is not the native language of all employees) in the context of the general "comprehension test", e.g. within an extended examination of the training success.

The already mentioned point 4.4 of the EU GMP Guide is always referenced for this requirement in the GMP area, because the requirement that style and language must correspond to the intended use also means that the employees must be able to understand the documents.

Point 4.2 of the EU-GDP guideline requires the documents to be worded in a "language that is comprehensible to the staff". This supports our interpretation of the EU GMP Guidelines. Both documents use the same English term "language".

 
GMP-Verlag Peither AG

Author

GMP-Verlag Peither AG
GMP Expertise for Your Safety.
E-Mail: service@gmp-publishing.com
 
 

Comments


SOPs written in 2 languages are often much better written as the sentences are often shorter and the contents clearer. A positive side-effect of bilingual SOPs. Regards Siegfried
Siegfried Schmitt 20.10.2019

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