Support for obtaining GMP certification at overseas manufacturing bases - Translation case of GMP-related documents

Overview of Pharmaceutical Manufacturers

・Capital: 100 million yen

・Number of Employees: 160

 Services

Medical Translation Services (Japanese GMP English Translation)

Background

In May 2018, we received a request for consultation on GMP document translation from a medical publishing company.

This is because it has been decided to manufacture active pharmaceutical ingredients at overseas locations and GMP documents are 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 each country.

Reasons for choosing Human Science Co., Ltd.

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

 

"I learned about Human Science through a GMP consultant I know, who was introduced to me by a publishing company."

I was unsure of the level at which GMP document translation could be carried out, so I requested a trial translation before placing an order.

 

In addition, we conducted trials with seven translators this time, and four of them were deemed to meet the desired quality and were accepted. We have many high-quality translators who have passed the trial and have the capacity, so we can be assured. (To the person in charge)

Translator's Career (Partial Extract)

Translator T.H. (Nationality: United Kingdom)

• ・37 years of translator experience
• ・Specialty: IR documents, medical and pharmaceutical texts
• ・Achievements: Tanabe Mitsubishi Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Osaka City Institute of Public Health and Environmental Sciences, Kyoto University iPS Cell Research Center

Translator A.K. (Nationality: America)

• ・27 years of translation experience
• ・Specialty: IR documents, medical and pharmaceutical texts
• ・Translation expertise: Clinical trials (protocols, clinical study reports, interim reports, case reports, investigational drug brochures, informed consent forms), pharmaceutical/medical device regulatory documentation and approval, regulatory consultations (applicant and 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)
• ・Experience: Pharmaceutical companies (approval review of new drugs, package inserts, guidelines, reports, investigation reports, etc.), medical devices, quasi-drugs, translation of materials for bio-related manufacturers (instruction manuals, catalogs, sales materials, etc.), medical papers, academic documents, translation of materials for academic conferences, proofreading

Translation Schedule

Divide the whole into four blocks for efficient progress

April 2018

・First-time inquiry and request for trial translation

May 2018

・Submission and Approval Notification for Trial Translation

・First request for quotation and order for actual project

June 2018

• ・First delivery
• ・Confirm that there are no issues with the translation of the first document
• ・Second request for quotation and order confirmation
• ・Consultation on efficient response schedule for the third estimate request
• 　After delivery from HS, proceed with the translation of the following items during the period in which the customer is conducting internal checks on the delivered goods. Modify the approach to eliminate time loss between HS and the customer.

July 2018

• ・Additional Trial and Notification of Successful Applicants
• ・Second delivery
• ・Contact and delivery for the third order
• ・4th Estimate Request

August 2018

・Delivered the fourth installment, project completed

September 2018

・Conduct project retrospective meetings

 

Evaluation of Human Science Co., Ltd.

A concrete path for active pharmaceutical ingredient manufacturing has become visible at overseas production sites.

"In order to establish GMP in a manufacturing facility without prior experience in GMP manufacturing, it is necessary to first create GMP documents such as procedures. However, the content is quite specialized and requires a strong understanding of science, GMP, and translation skills."

The translation quality of Human Science is very good, and there were hardly any areas that needed to be revised in the end.

We are also satisfied with the progress of the schedule.

In this project, there was a need to translate many GMP-related documents.

Even though we outsourced the work, secondary checks within the company were necessary, so we had to control the delivery schedule from Human Science to a manageable amount for internal checks. However, Human Science responded according to the schedule we provided and we were able to smoothly proceed with the work, which was a great help.

"We are very pleased to have entrusted Human Science, which has both quality and schedule adjustment capabilities. We are very satisfied with their response. (Contact person)"

 

Related Services

Medical and Medical Translation