JP drafts for public comments, March 1 - 31, 2023
New General Information
- Analyses of Size and Morphology of Nanoparticles by Atomic Force Microscope〈G1-9-182〉[193KB] (001-2303eng.pdf)
- Flow Cytometry 〈G3-16-182〉[162KB] (002-2303eng.pdf)
- Evaluation Method of Insoluble Particulate Matter in Biotechnological Products (Biopharmaceuticals) Drug Substances / Drug Products by Flow Imaging Method〈G3-17-182〉[143KB] (003-2303eng.pdf)
General Test and General Information related to Balances
Please refer to the Briefing Note[98.1KB] as well.
Revised General Test
- 9.62 Measuring Instruments, Appliances[94.1KB] (004-2303eng.pdf)
New General Information
- Concept of Weighing in the Japanese Pharmacopoeia 〈G1-6-182〉[66.3KB] (005-2303eng.pdf)
- Calibration, Inspection, and Weight of a weighing instrument (balance) 〈G1-7-182〉[70.0KB] (006-2303eng.pdf)
- Installation Environment, Basic Handling Method, and Precautions for Weighing of a Balance 〈G1-8-182〉[77.7KB] (007-2303eng.pdf)
To send the comment on these drafts, the guidance is as follows:
- Download the form for comments in Word format[67.0KB]
- Fill in the form
- Prepare and attach the supportive data that scientifically validate the comment when appropriate
- Send it to the email address: JPdraft-eng[at]pmda.go.jp
Note:
For the purpose of security, this email address is partly incorrect. Please replace [at] with @ when sending an email.
Note:
The information submitted with the comments may be released to the public whenever necessary (except the individual name, organization, address, telephone & fax numbers and e-mail address or the attached supportive data).
Your comments will be considered for the preparation of JP final drafts, but no individual response will be made to each comment.