Pharma QM

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

Availability

Monday : 13:00-17:00

Contact me

Please send e-mail to:

q12.hataconsul@gmail.com
Naotaka Hata

Blogs

（Next release: May 13, 2025）

The practicing of quality culture is the best way to build a quality system based on ICH Q10 and bringing it closer to completion. However, ICH Q10 does not take into account how people feel, think, and act, therefore I think improving the state of mind (of each person) to a more desirable one is the core message we should learn for quality culture.

In order to make yourself more useful to the organization, I think that a more desirable organizational culture and better work results can be achieved by thinking about how to accept the current situation, thinking about what to do, and being able to talk frankly around you. When you accept the current situation and think about what the ideal situation would be, you will sense what the issue is and what is missing, and think about how to improve. Constantly talking with each other, you can unite the power of each individual.

Some issues about workplace atmosphere may be the motivation of those involved, unclear requests and working instructions. Work often cannot be completed by one person, so if each person thinks more about making the most of their own area of ​​responsibility and practices it sincerely, people will support and complement each other more, and the efficiency in the workplace will increase.

Furthermore, the ability to feel, think, and act is something that each individual has cultivated at home, so the same approach should be taken at home: accepting, supporting each other, and having frank discussions with your family.

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.

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)