Translation examples of GMP-related documents Support for obtaining GMP certification at overseas manufacturing sites

Overview for Active Pharmaceutical Ingredient Manufacturers

・Capital: 100 million yen

Number of Employees: 160

Services Utilized

Medical Translation Services (Japanese GMP English Translation)

Background

In May 2018, we received an inquiry about GMP document translation through a referral from a medical publisher.

It has been decided to manufacture active pharmaceutical ingredients at overseas bases, and GMP documentation is required.

Specifically, we were considering translating the GMP documents used at our manufacturing facilities in Japan and using them as a template to create GMP documents for our overseas locations.

*GMP stands for Good Manufacturing Practice, which is a standard for manufacturing and quality control of pharmaceuticals and other products. It is established by various countries.

Reasons for Choosing Human Science

High translation quality with a solid foundation of medical knowledge and reliable capacity

I learned about human science through a GMP consultant I was in contact with, who introduced me to a publishing company.

I was unsure at what level the translation of GMP documents could be performed, so I requested a trial translation before placing an order.

Additionally, we conducted trials with seven translators this time, and four of them were deemed to meet the required quality and were accepted. We have many high-quality translators who passed the trial, and we have the capacity, which gives us peace of mind. (To the person in charge)

Translator Profiles (Partial List)

Translator T.H. (Nationality: United Kingdom)

・37 years of translation experience
・Specialization: IR materials, medical and pharmaceutical texts
・Achievements: Tanabe Mitsubishi Pharma Corporation, Chugai Pharmaceutical Co., Ltd., Osaka City Institute of Public Health and Environmental Science, Kyoto University iPS Cell Research Center

Translator A.K. (Nationality: United States)

・27 years of translation experience
・Specialization: IR materials, medical and pharmaceutical texts
・Specialized Translation Knowledge: Clinical Trials (Protocols, Clinical Study Reports, Interim Reports, Case Reports, Investigational Drug Brochures, Informed Consent Forms), Regulatory Documentation and Approval for Pharmaceuticals/Medical Devices, Regulatory Consultations (with the Pharmaceuticals and Medical Devices Agency (PMDA)), Periodic Safety Update Reports (PSUR), Post-Marketing Surveillance, Pharmaceutical/Medical Device Package Inserts, Patents Related to Recombinant Technology, Biochemistry

Translator M.A. (Nationality: United Kingdom)

・7 years of translation experience
・Bachelor of Science (Molecular Biology)
・Achievements: Translation of materials for pharmaceutical companies (new drug approval reviews, drug manuals, guidelines, reports, research documents, etc.), medical devices, quasi-drugs, and bio-related manufacturers (user manuals, catalogs, sales materials, etc.), translation and proofreading of medical papers, academic documents, and materials for conferences.

Translation Schedule

Divide the entire process into four blocks for efficient progress

April 2018

- Initial Inquiry and Request for Trial Translation

May 2018

・Submission of trial translation and notification of acceptance

・Request for quotation and order for the first actual project

June 2018

Delivery of the first batch
- Check the translation of the first draft document and confirm that there are no issues
・Second Request for Quotation and Order Notification
Third request for a quotation, consultation on an efficient response schedule
　After delivery from HS, during the period when the customer is conducting internal checks on the delivered items, we will proceed with the translation of the next items. Adjust the approach to eliminate time loss between HS and the customer.

July 2018

・Notification of Additional Trials and Successful Candidates
Delivery of the second batch
- Contact and delivery for the third order
・Request for the fourth estimate

August 2018

・Delivery of the fourth installment, project completion

September 2018

- Conducted a project review meeting

Evaluation of Human Science Co., Ltd.

A clear path for the production of active pharmaceutical ingredients at overseas manufacturing sites has emerged.

To establish GMP in a manufacturing facility that has no experience with GMP, it is first necessary to create GMP documents such as procedures. However, the content becomes quite specialized, requiring a foundation in science and GMP, as well as translation skills.

The translation quality of Human Science is very good, and there were almost no areas that needed revision at the end.

I am also satisfied with the progress of the schedule.

In this project, it was necessary to translate many GMP-related documents.

Although we outsourced the work, we still needed to conduct a secondary check in-house, so we had to control the delivery schedule from Human Science to a manageable amount for our internal review. However, Human Science adhered to the proposed schedule, which allowed us to proceed smoothly with the work, and we were greatly helped by that.

I am glad to have asked Human Science, which has both quality and scheduling capabilities. I am very satisfied with the response. (To the person in charge)

Related Services

Medical Translation