Pharma QM

Services

・QA Support

4,500 yen/hr (excluding tax, transportation)

・Lecture

9,000 yen/hr

Abailability Monday - Friday: 9AM - 4PM

Contact

Please contact me:

q12.hataconsul@gmail.com
Naotaka Hata
Pharmaceutical guidances study: 29 years
Pharmaceutical/Investigational drug QA: 9 years
Pharmaceutical/Investigational drug Analysis: 13 years
Product planning and coodination: 7 years
Member of industry association: 12 years

Blogs

（Next release: September 13, 2026）

Additional supply chain reference (May 10, 2026)

Covid-19, Trump-tariffs and the Iran war have been changed the pharmaceutical supply chain guide in unanticipated ways.

PIC/S has opened the concept paper of its GMP annex 15, Qualification and Validation, saying that it will be expanded to be applied to the drug substance and also contain a GDP requirement to the drug substance (January 2026).

IPEC, International pharmaceutical excipients council, has updated its stability guide saying that they require to have a stability data of excipient by warehouse storage, in lieu of stability testing or formal stability testing (March 2026).

MHLW has released a notification that the specifications and test methods for the initial drug application using USP-NF or EP specifications is possible tentatively, but they will be required to change to JP specifications afterwards (April 2026). These changes of guidance　have seemed to occur randomly, but they probably occurred as an industry effort to adopt to the change in time. We need to adjust ourselves and our organization accordingly.
(Photo of azalea in Yokohama)

Revision of stability testing, ICH Q1 (Sep 21, 2025)

Revision draft of ICH stability testing has been released and almost all chapters have been updated. This guideline will be applied to not only chemical products, but also proteins, vaccines, co-packed diluents, as well as ATMPs. The main body of the draft begins with the stability testing in the development stage (Chapter 2), which points to two types of studies, accelerated and forced degradation studies, useful for product knowledge and handling deviations (Deviations do not necessarily have to be handled by the GMP study).      
   The accelerated and forced degradation studies are also useful for the design of primary stability testing (Chapter 3). Stability modeling is an evaluation based on one degradation pathway of the compound, where by appling the Arrhenius reaction calculation can obtain the period of the compound reaching to the lower limit of specification (Appendix 2).
LED light is now as an option for photo stability testing on a limited basis for the test, considering of the cost and the supply of the light source (Chapter 8).
Stability of intermediates of drug substances and drug products should be evaluated (Chapter 9) and short term storage conditions should be described for necessary cases (Chapter 10).
The definition of the manufacturing date of drug product has now been proposed as the first day of the mixing of API with another ingredient. However, different or additional definitions are allowed depending on the circumstances of each country (Chapter 13).
Change control, e.g. changing the packaging might be more flexible by evaluating the stability profile of the products, which leads to possible alteration depending on each country’s regulations.
Reducing stability testing measurements will be further elaborated on the training material of reduced stability design in the near future.

Revision of ICH Q1 (May 9, 2025)

Step 2 draft of stability testing is now available and it is a comprehensive guideline. The following are the future changes:

• When developing products, you should consider the necessity of thermal cycling and freeze/thaw studies.
• Before initiating stability study, CQAs should be identified.
• For the primary stability testing, 3 batches should be of pilot scale for the drug substances, while at least 2 batches should be pilot with 1 batch can be smaller for drug products.
• When multiple manufacturing facilities are used, quality data of each location are necessary and the necessity of stability should be considered.
• Products stored at -20 or below -20 degrees, the accelerated condition should be 5, 25 or 30 degrees.
• A third option LED lamp has been added for the photo stability testing.　Main wavelength should be more than 400nm.
• Conditions of confirmative photo studies are the 1.2 million lux hr and 200 watt hr unchanged.
• Forced photodegradation is examined by doubling the level of confirmative study, but when a milder condition is suitable, 43-260 lux hr and 0.3-3 watt hr can be used.
• Consideration of the stability of intermediates are necessary.
• When the short-term stability is necessary for patients, such as the storage at the room temperature of a refrigerated drug product, this should be stated on the labelling.
• 2 batches are used for in-use stability consideration.
• The start of the shelf life of a drug product should be the date of production, date of first manufacturing date. However, when the date of release is less than 30 days from the date of production, the date of release for the batch could be used as the start of the shelf life.
• For the evaluation of stability data, consideration of stability modeling can be used.

Now the necessary items about stability testing are combined in one document.

Quality management through quality culture (Jan 12, 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.

Prosperity of the organization (September 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.

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

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)