Translating SOPs in a Pharmaceutical Manufacturing Environment

hese are comments on the general practice of translation and specific issues I have found in translating Standard Operating Procedures, SOPs, in a pharmaceutical manufacturing environment, which I offered at the ATA Seminar on Translation in the Pharmaceutical Industry held on January 24 in San Juan, Puerto Rico. The materials were gathered by José Rodriguez, Gloria Colón, and others who work with us at a pharmaceutical facility in Juncos, Puerto Rico. While sorting through the records our work team has kept of issues we have encountered, mostly in SOPs, but many in other controlled documents, such as documented practices, and non-controlled documents, such as letters from government agencies or press releases, we tried to cull what we feel are interesting examples that may be helpful to others.

Language is so contextual that even the most carefully written text may be subject to interpretation.

The one caveat that we have is that we work between US English and Puerto Rican Spanish, so that our specific terminological examples are limited to those languages. We work in both directions, addressing regulatory compliance, which means that documentation should be in English, to be readable to federal regulators who are English-speaking, and production issues, which means that an SOP has to be understood by the Spanish-speaking worker.

I think that it is becoming clearer every day that translation is a very serious activity that requires extensive training to be done properly. It is also an activity that cannot be carried out adequately in isolation or assuming that the work to be performed is a known quantity, whether in terms of the raw materials (the document to be translated), the process (the actual translation), the principal agents of the process (translators), or the product (the translated document). This is not only the case for translation in the pharmaceutical industry, but for all translation. What I will try to do is to address some general translation issues as they apply to pharmaceutical manufacturing documents, and then discuss some terminological issues.

Although it would seem that the only unknown quantity at the beginning of the translation process is the final outcome, in fact the original document, which was assumed to be a reasonable text, on close examination is often found to be less than transparent. The presumption that the original document is a kind of ore that can be refined to obtain a specific quantity of a given metal is, unfortunately, not grounded in reality. Language is so contextual that even the most carefully written text may be subject to interpretation. A case in point is a comment made by a member of the pharmaceutical industry with regard to an FDA Guidance and which was published in a docket on the FDA website:

"3. Narrow Interpretation (Lines 118, 119) 'Part 11 will be interpreted narrowly;'—FDA needs to define the implication of a 'narrow' interpretation and possibly define this in a glossary document. Unless defined, a narrow interpretation is just as assuming as a 'broad' interpretation might be. If the definition and interpretation of the term is left to the Pharmaceutical Industry, then a narrow interpretation has become a broad interpretation because it is left once again for the user of the rule to make their own definition."¹

In this case, the reader is turning to the originator of the document for clarification, which is exactly what we must do before initiating the translation process with SOPs. If we are not certain we understand the original, it will not be possible to produce a reliable translation. I am not talking about unusual terminology or phraseology, I am talking about words like "narrow" and "interpretation" as used in the example I just mentioned. There are things from simple, daily language like "face up"; descriptions of time, "within 24 hours before shipment"; composite terms like purchaser/planner; and logical gaps, such as the sudden appearance of a third filter in a sequence in which two filters were being mentioned, all of which may have seemed very clear to the originator, but on careful reading becomes ambiguous.

Face up? Well we had to ask, how can a gasket be face up? For something to be face up, it should have a face. Does a gasket have a face? The outcome of that inquiry was to eliminate the phrase "face up" and describe how the gasket would fit in to where it should be placed.

We asked: Does within 24 hours before shipment mean 24 hours or less before shipment or 24 hours or more before shipment? We're waiting on that one.

Does purchaser/planner mean the purchaser or the planner, or does it mean a person called a purchaser planner? It means a Purchaser Planner, as they used to be called before slashing became so prevalent.

When did the third filter parachute in? Well, the first filter was being replaced by a second filter, but there was a standby filter which could also need replacement, which would mean in fact there would be four filters on hand. The text was rewritten.

The only way to deal with these problems adequately is to ensure access to the creator or creators of the document. We are fortunate that we work in an environment where it is relatively easy to find the originator (or originators) of the documents we translate, but that doesn't mean that translators in other circumstances shouldn't insist on having some kind of access to the author of the document. Even people who are familiar with the processes and the equipment involved will frequently say things like "I don't think that that is the correct sequence, but you will have to ask the person who wrote that," so it is not a question of having a subject matter expert, but rather a question of verifying what is being stated. Non-native speakers of English are surprised to find out that the fact that something was written in the United States by native speakers of English is no guarantee that the text is clear and that the text copied from documents written in the US is not what they thought it was.

When clarification of a document results in changing the original, these changes can be recorded as revisions in the section of the SOP called the document history, in order to ensure regulatory compliance. We have found that people are sensitive about phrases such as "spelling and grammar were corrected," but will accept "changes made in spelling and grammar" as a comment in a document history. Substantive changes such as changing the word "verify" to "check" should be specified. These changes in an original text that are a product of a translator's reading should be perceived as a side benefit of translation, and not as undue interference. Translators who do not have this option would be wise to advise their clients in writing of all ambiguities or contradictions in the original. We all know who will be held accountable for ambiguities and contradictions in the translated version.

Another issue that I consider a general issue of translation is that a substantial number of documents are not strictly written in one language or contain elements that should be not be translated. Examples are abbreviations such as i.e and e.g. that are not in English, and are frequently misused in the original, as well as terms in Latin, such as the names of bacteria. Examples of language that must not be translated are the texts of computer displays, words on computer or equipment interfaces, and trademarks. Here again, the translator must have access to information that may not be obvious from the document itself. An instruction may refer to a term that would seem to be a plain word, such as storeroom, for example, and the storeroom may not be a place, but a designation in the computer system. The word may not have a marker such as quotation marks or an initial uppercase letter, but a careful translator will notice that the text is not referring to a usual meaning of the word. A button may be a reset button, which in fact has the word "reset" written on it. The original says "press the reset button." We translate the sentence as "press the button "reset," (presione el botón "reset") and translate what "reset" means or state the effect of pressing that button (presione el botón "reset" para reiniciar el equipo." Once again, the translator needs to have access to an informed source in order to ascertain the meaning of the original. In the case of computer displays and equipment interfaces, in many cases illustrations will provide enough information, but the translator should be wary. Recently I had to ask the person who used the equipment why an instruction said "press the reset panel" when the illustration showed a button on the panel. His answer was that in fact what should be pressed was the reset button on the panel. The illustration legend said "reset panel" with no mention of the button. I will go into the issue of trademarks a little later when I discuss manufacturing terminology.

Once we have a reasonable grip on the original, we can begin the translation. Here, terminological issues come to the fore, and in the case of SOPs, the grammar of instructions. Most of our work is translation from English into Spanish, but some SOPs are written in Spanish, or have been translated into Spanish and now must be retranslated into English, generally with a view to creating bilingual documents, as I mentioned before. I will only address specific problems we have come across in translating into Spanish, since the documents to be translated into English are heavily influenced by earlier translations into Spanish, so that terminological issues can generally be solved by referring to an earlier version of the English-language document.

One question that has to be dealt with is how instructions are expressed. In the original there may be variety in the mood, voice, and person of the verb, an indication of whether the action to be performed is required or optional, whether the action is contingent (if...., when...., after...). An SOP step may say something like the associate shall clean the filter, followed by a list of steps in the imperative: "Remove the filter, place the filter...." The final step could be a description in the passive voice, "cleaning shall be performed once a week," or "cleaning shall be performed by the associate once a week." In the translation it may be necessary to change this style to ensure that the instruction is clear. A step such as "Cleaning shall be performed once a week" may be translated as "El asociado limpiará el filtro una vez a la semana." The translation adds the subject and explicit object of the action to be performed, using the active voice, since a direct translation, at least in Spanish, would be too open. Another question is that in Spanish the future tense implies obligation, so that it becomes unnecessary to use an auxiliary verb. The thorny question of "shall" and "will" disappears in terms of actions to be performed.

The complications of the English verb do not end with the manner of expressing instructions. One of the ways in which words are created in English is what is may be called "verbing." We have a pipette, and what do we do with the pipette? We pipette a solution. We have a centrifuge, so we centrifuge our raw material. We need to prepare a kit, so we kit the parts. As matter of fact, the custom is not entirely restricted to English. We do have "centrifugar" in Spanish. We most definitely do not have "pipetear," although we have a "pipeta." The translator has to determine from the verbed noun what it is that is being done. To gown is to put on your gown (and to de-gown is to take it off), to kit is to prepare a kit, and so forth.

Another issue we have had to be careful with is that in English things can be checked for, as for example, check for leaks. In fact, what is being instructed is to ensure that there are not any such leaks. If we translate check for leaks straightforwardly, we may be conveying the opposite: we are in fact making sure that there are leaks. This is another instance in which the translation in effect adds information. The original merely states that the person is to determine whether there are such leaks, a kind of information-gathering exercise, with no consequence for action. In Spanish at least, the clearest way of conveying the purpose is to state the purpose of the examination explicitly: "Compruebe que no haya ningún escape.."

And now for terminology.

In our work team we are constantly building a glossary based on the documents we are working with. For this we are using straight word processor tables and basically a word for word equivalence with very little contextual information. We are currently trying to establish a different methodology, and I hope we can even find a way to have terminology management recognized as a worthwhile full-time occupation in and of itself. We devote a disproportionate amount of time to terminological research, especially since we work in a relatively new and very dynamic area of the pharmaceutical industry, biotechnology. Our documents are also subject to regulatory compliance, so that we have to be aware of regulatory terminology, not only with regards to the FDA, but notably also with regards to the EPA and local authorities.

Our terminology sources, aside from the personal consultation I have emphasized so much, are the dictionaries mentioned in the bibliography we prepared and manufacturers' manuals that are kept in our work area, as well as Internet resources. In terms of Spanish, Internet access is especially vital. The Real Academia is on-line and updates are included in the on-line version of the dictionary. On January 15th over 2,500 new entries were added to the dictionary, but not as a separate list. Although we continue to have to check to see whether an individual term has been accepted by the Academia on a word by word basis, at least it is a relatively painless process.

In terms of Internet use, I am sure you are aware of the major search engines and how to modify searches to find what you are looking for. We have found that it is useful to include the word "glossary" or the word "glosario" next to the term we am searching for. We have also been successful in using manufacturers' sites for consultation as well as professional organization and educational institution sites, notably in Spain. We are also well-aware that not everything we find may be taken at face value, but that has been the case with printed dictionaries forever.

There is an ISO Standard for Translation-oriented Terminology, ISO 12616 which includes an extensive description of the preparation of a terminology database. I will not go into the text of the Standard, but I urge all of you to look at it.

The terminology categories that I am going to mention here are much simpler than those of the ISO standard. The categories are everyday language, manufacturing terminology, and finally, pharmaceutical terminology.

It would seem that everyday language should not represent any problem for a practicing translator, yet the first order of terminological issues in the SOPs is in fact constituted by words that do not require a dictionary for translation.

One of the most important aspects of pharmaceutical manufacturing is water management. The source of the water used by the manufacturing facility is important for many reasons, including the mineral content and legal issues that include ownership and environmental controls. One of the terms that is repeatedly encountered is city water, a concept that is non-existent in Puerto Rico inasmuch as most water is provided through a Commonwealth agency. There may be manufacturing facilities with their own springs or wells, but those sources would not be called "city water" either. When I brought this up, however, I was told that the industry used the term. This is a case in which a very everyday term, "city water," a term that causes no problem in the United States, where water is usually a city utility, is non-existent in the place where the document is to be used. In fact, to talk about city water at all in Puerto Rico is not a good idea. I believe there is one municipality that has municipal wells or springs, and to use the term in either language may bring up unwanted legal issues.

Another totally unexpected example was the mention of a pants cuff in an SOP about acceptable attire. Pants are not supposed to have pants cuff, so this was an important question. The issue is that men's pants rarely have cuffs anymore, especially in the work place. In addition to using the word "dobladillo," the Oxford-Duden Visual Dictionary term for this part of men's attire, we specified that the pants were supposed to end with a straight hem.

A term that is part of daily vocabulary is the word styrofoam. I have included as a handout a table showing the alternatives found by Andre Moskowitz in his on-going research endeavors, as well as what we found in some dictionaries. We ended up using "espuma de poliestireno," but I would hope that in the future somehow we could promote the use of "poliespuma," which is so easy to say and avoids the use "estairofon" or "fon."

There are many more examples but I would like to move on to the category of manufacturing vocabulary. Whereas there are many terminological issues regarding machinery and processes, the two most difficult areas in my view are the use of trademarked terms, acronyms and abbreviations. In the SOPs there are constant references to things such as Tri-Clamps, BioShield and TackyMats, all of which are trademarks. In the case of the Tri-Clamp, I asked and I was told that the connectors in question were not necessarily Tri-Clamp brand, but a certain kind of connector known to at least the local site's workers as triclamps. The solution in translation for this is "un conector tipo Tri-Clamp," a Tri-Clamp type connector, with Tri-Clamp written in upper case. BioShield represents a problem in terms of Bio Shield spray being made by one company and a BioShield sterile paper product of different sizes made by another. The translation solution is to specify "papel estéril BioShield." The last example, TackyMat, is translated as "alfombra bioestática TackyMat." In the latter two examples, the items being used are in fact the trademarked items. In all three cases, we know that what people will call them in real life will in fact be the trademarks, but the written documentation must specify a description in natural language of what the object actually is.

Abbreviations are here to stay. In our practice, we write out the words represented by the abbreviation the first time we include them in the document. In some cases, an abbreviation exists in Spanish and in others, the translation will include the indication that the English abbreviation will be used, "procedimiento operacional estándar, conocido como SOP, por sus siglas en inglés," that is to say such and such known by its abbreviation in English. There may be occasions in which the term is so short in Spanish that it may not be necessary to use an abbreviation or acronym, or the acronym is a word in Spanish. An example is EN, equipment number, número del equipo. On a form it would be necessary to write an abbreviation but in the actual SOP it is better to write out the phrase.

Abbreviations lead us into the pharmaceutical industry, head on into the land of the cGMPs and mRNA, the FDA and the CDER. Here, what immediately stands out is that the abbreviation is no longer constituted by uppercase letters. What is that lowercase c in the cGMP? Well, current good manufacturing practices are referred to as cGMP's in the FDA literature, although a careful search of the FDA site will yield an all uppercase CGMP. Messenger RNA, and then all kinds of variants of RNA and DNA carry a lowercase modifier as part of the abbreviation. Things get really complicated when we get to recombinant human erythropoietin (r-HuEPO), lower case r, hyphen, uppercase H, lowercase u, uppercase EPO. The Vocabulario Científico y Técnico of the Real Academia de Ciencias Exactas, Físicas y Naturales, 1996 edition, includes these hybrids in their English format. The effect of this is that Spanish abbreviations like ADN and ARN, which had gained currency, are tending to revert to the English forms, DNA and RNA, in order to be consistent with the modified forms. In terms of pronunciation, who knows what this is going to produce. We have in Spanish: rHuEpo (lowercase for the r, the u, the p and the o, by the way), "la forma recombinante humana de la eritropoyetina," used in a description of a treatment, "la identificación y desarrollo clínico de la forma recombinante humana de la eritropoyetina (rHuEpo) significó una evolución en el manejo de la anemia."²

There is also terminology that is not so new, but not readily available in paper resources, words such as "pipettor," and phrases constituted by what would seem like plain language, such as "therapeutic sales." Pipettors are referred to as "pipetas electrónicas" most generally on the Internet. The phrase therapeutic sales (how could a sale be therapeutic?) in the context meant that the product was ready for the pharmaceutical market.

Perhaps the most difficult term that we deal with is the term "bulk." Bulk and bulk manufacturing in the pharmaceutical industry do not refer to the same thing as bulk in other industries. These terms as applied to materials in the pharmaceutical manufacturing process refer to the processing of raw material to create an intermediate material in bulk form, which will be further processed or formulated into the final drug product or therapeutic. The term "material intermedio" has some currency, and we hope that we can move on from the current policy in our facility of retaining the term "bulk," or especially "purified bulk," in English.

I hope that these remarks are of use to you. As a translator, what I cherish is that our field is dynamic. What we have to offer is that we know how to suspect, how to mine, how to fish, and how to offer possibilities. In closing, I would like to offer you the true meaning of the term translation, which came my way while I was looking for something else, as usual:

"Translation: The process in which the genetic code carried by mRNA directs the synthesis of proteins from amino acid." He dicho. Thank you.