ENHANCING MEDICAL DEVICE & PHARMA SOPS WITH TRANSLATION SERVICES

Discover how professional translation services ensure clarity, consistency, and accuracy in translating SOPs for global operations.

Standard Operating Procedures (SOPs) ensure consistency, efficiency, and quality in your operations. That’s why regulatory bodies require creating and enforcing these written procedures for the production of pharmaceuticals and medical devices.

Now, when outsourcing manufacturing to another country, translating and localizing your SOPs is a must. After all, how else would foreign workers get acquainted with your workflows?

Learn how to boost SOP effectiveness for readers in different countries in our blog post.

What is an SOP?

Standard Operating Procedures (SOPs) are sets of step-by-step instructions documenting the most common tasks at a company. They provide your staff with clear guidelines to perform their work consistently.

For example, an SOP may outline the steps for handling, testing, and storing the raw materials used in cardiac monitoring device production.

Why do you need an SOP?

As a medical device or pharmaceutical company, your SOPs lay the groundwork for a robust quality management system. They address process requirements to ensure your products are safe and effective.

In essence, SOPs serve 5 key purposes.

  • Consistency and quality control

SOPs standardize procedures. Your customers can expect the same product with consistent quality every time.

  • Productivity

Having clear guidelines optimize workflows and reduce delays.

  • Compliance

SOPs outline regulatory requirements, ensuring you comply with industry standards.

  • Knowledge transfer

SOPs make it easy to share best practices within the company.

  • Training and onboarding

SOPs provide a structured guide for new hires, expediting their training process.

How can you make your SOPs more effective?

Improve the impact of your SOPs in your organization with these tips:

1. Write your SOP for your end user

A common mistake when drafting SOPs is to try to cover every eventuality with a view to passing your quality inspection.

Instead, think of how you’d describe the process to someone who knows nothing about it, and ask yourself these questions:

    • Have I written clearly, with brief sentences and simple terms?
    • Have I used a step-by-step format that makes it easy to follow the procedure?
    • Have I avoided vague terms such as “periodically”, which may lead to different interpretations?
    • Have I formatted the SOP using bullets and lists?

2. Follow the same structure in all your SOPs

This will help readers become familiar with your procedures. An effective template includes:

    • Header: include a title to identify the activity, the document number, and the version.
    • Introduction: outline the purpose and scope of the SOP (i.e. the intent of the document and to whom or what it applies).
    • Approvals: add pertinent signatures and date of signing.
    • Table of contents: make it easy for the user to locate information within the SOP.
    • Definitions and abbreviations: spell out the meaning of any terms or acronyms that the end user may not understand.
    • Procedure: break it down into all the steps necessary to perform the task.
    • Revision history: record what changes are made, when and why.
    • References and related documents: include links to regulations and other relevant references.
    • Appendixes: add visual explainers for procedures.

3. Avoid jargon and convoluted language

You want your readers to understand what they are supposed to do. So, steer clear of technical words. Also, rephrase regulatory guidelines in simple language rather than copying them word-for-word.

4. Add visual aids

Using pictures, diagrams, and flowcharts for better process understanding.

5. Use work instructions

For long SOPs, provide detailed step-by-step guidance using work instructions. In this context, the SOP functions as a comprehensive document in your native language, while the work instructions can be translated for each specific user group.

How can professional translation enhance your SOPs?

If your operations span different locations, translating your SOPs is a must to ensure a consistent understanding of procedures among your staff.

Now, you should rely on a subject matter expert for the translation of such a crucial document. Here’s what you stand to gain:

  • Double-checking that your SOP is accurate and clear

While working with the original SOP, the translator may identify clarity issues or passages that are open to interpretation. This will give you a chance to correct the original document.

  • Ensuring no omissions

As your translator reviews the procedural steps, he/she may notice minor actions or details that have been skipped by mistake.

  • Choosing the right terminology consistently

Knowing which terms to keep in the original language and which ones to translate is crucial to prevent confusion for your SOPs’ users.

  • Making sure the translated SOPs are compliant

Life science translators stay current with industry standards and help you meet regulatory requirements.

  • Addressing cultural subtleties

The original document may include phrases or metaphors that only make sense to native readers. Your translator will know how to convey the same meaning in a way that resonates with your audience.

  • Using the right abbreviations

Some abbreviations are specific to the original language, while others may have local alternatives. The decision on which one to use should be made case by case, considering what is most understandable for the readers.

As you can see, translation services can pave the way for a seamless, compliant, and globally understood workflow. Appoint a translator with subject matter expertise in your industry for the best results.

Look no further! We have a pool of linguists who are experts in pharma and medical device manufacturing.  Contact us for more information.

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