Support for: Pharmaceutical guidances and rules implementation, documents generation (Data Integrity and Quality culture implementation, CTD submission), training, mock-audit and interpreter for audit.

Guidance Training

Rules for Marketing approval and GMP differs in each country. Every country has its rules added to the harmonized guidance, so that environment and situation are explained.
(Photo: Presentation at US conference)


Documented Procedures

Internal documents and SOPs will be generated to adopt internationally harmonized guidance considering the suitable level of implementation for your organization.
(Photo: Communication time at Czech conference)

Documents Generation

Acceptable documents and papers will be generated (CTD etc.)
（Photo: Time after presentation in Toyama Japan)

Mock-audit, Interpretation

Supprt and help for inspection available
（Photo: Presentaion at US conference）

Services

・Guidance Training

　　・Features of Japan, US and EU quality guidances
　　・Updated GMPs (including requirements for each contry)
　　・Stability Testing in development and in production

8,000 yen/hr (excluding tax, transportation)

・Brush up SOPs

　　・Update for quality SOPs (QM, QA, QC)

4,000 yen/hr

・Documents Optimization

　　・Documents for submission (CTD, reports for customers)

4,000 yen/hr

・Mock-audit

　　・API
　　・Dosage form, Drug product

4,000 yen/hr

・Interpretation

　　・FDA or customer audit interpretation, English to Japanese

4,000 yen/hr

Carrier
Naotaka Hata, PhD has an experience of:

・Pharmaceutical quality guidance survey: 26 yrs
・Quality assurance for Drug products and Investigational new drugs: 9 yrs
・Analytical testing: 13 yrs
・Product planning and coordination: 7 yrs
・Pharmaceutical industry associations member: 11yrs
Availability
Tuesday, Wednesday: 9:00-17:00
Friday:　　　　 9:00-12:00
Monday, Thursday: Possibly adjusted
Contact me
Please send e-mail to:
q12.hataconsul@gmail.com
Naotaka Hata

    Blog
    （Next release: Jan 8, 2025）

    The prosperity of an organization (Sep 16, 2024)

    The series of people’s jobs are related, so it is important to connect all of them.

       As a general approach, we control a work by designating target standards and describing procedures. And if the result matches the target standard, we think the work has been done appropriately. However, when we imagine preventing mistakes or promoting the prosperity of an organization, we notice more underlying issues.

       In order to better connect individuals’ jobs, the important thing is the mind and how you handle each person’s performance. These are:

    • Their wish to contribute to the society, and
    • Talking and discussing your thoughts and feeling to other people involved in the job.

    Maybe we need a little bit more sincere responsibility rather than just performing described procedures.

       This responsibility awareness is naturally different among person to person, and it may be difficult to harmonize how much responsibility we have. By discussing it among everyone in the organization, I think it will unify the way an organization approaches its work and produces results. Not only will the results be better, but by harmonizing and acknowledging each other’s thoughts and attitudes, each individual will find their work rewording, valuable and acceptance from customers. Consideration of both one’s self and colleagues at the same time, thus, brings the prosperity of the organization.

    About DI in Japan (Jul 1, 2024)

    Description and consideration:

    Data Integrity (DI) has been an issue in Japan as it has been internationally, and many companies have established SOPs specific to DI.  DI is very briefly described in three guidances in Japan, which are:

    • Article 20 of Revised GMP Official Notification 2021
    • Item GMP 20-13 of GMP Case Studies 2022
    • Chapter 2 Item2-1 Legal Compliance for Pharmaceutical Manufacturers Official Notification 2021

     The Data Integrity provisions include:

    -      DI must be assured and records continuously controlled.

    -      Records must include an audit trail as written in PIC/S DI guide, and record integrity must be assured.                  

    -      Records must be appropriately and accurately recorded.

    At a 2024 Round Table Discussion event, members of Japan’s PMDA, industry associations and pharmaceutical companies gathered to freely discuss a variety of issues, including Data Integrity.

    One member of the PMDA authority suggested that the important issues of DI are:

    • Education
    • Systemization
    • Inspection
    • Leadership of DI managers
    • Commitment of senior management

    (https://www.pmda.go.jp/files/000267263.pdf)

    Meanwhile, the US FDA has issued its latest DI guide in the form of a Q&A document, expanding upon the provisions of its earlier 2018 Data Integrity Guidance. The EU and  PIC/S published a DI guide in 2021 to accomplish DI in a systematic approach. When considering the above situation, DI must be tackled by each organization for itself, in a balanced and appropriate way.     
    (Photo: Strolling in Shiga-kogen with industry members)