JP Drafts (September 2021) No.2

JP drafts for public comments, September 1 - November 30, 2021

New monographs

• Anastrozole Tablets (003-2109eng.pdf) 
• Bicalutamide Tablets (004-2109eng.pdf) 

General Tests and General Information related to Chromatography

     Please refer to the Briefing Note as well.

　New General Test

• 2.00  Chromatography (005-2109eng.pdf)

Note: 
Due to the progress in harmonization of G-20 Chromatography, the description of line 420-423 in the JP draft were changed as follows:
Before the change: ^◇To verify the suitability of the method under the new conditions, assess the relevant analytical performance characteristics potentially affected by the change._◇
After the change: To verify the suitability of the adjusted pharmacopoeial procedure, assess the relevant analytical performance characteristics potentially affected by the change.

　Revised General Test

• 2.01  Liquid Chromatography (006-2109eng.pdf)
• 2.02  Gas Chromatography (007-2109eng.pdf)

　New General Information

• Control Strategies and Change Control Concepts at Each Stage of Lifecycle of Chromatography (Change Control in Lifecycle of Chromatography)〈G1-5-181〉 (008-2109eng.pdf)

 

To send the comment on these drafts, the guidance is as follows:

1. Download the form for comments in  Word format
2. Fill in the form
3. Prepare and attach the supportive data that scientifically validate the comment when appropriate
4. Send it to the email address: JPdraft-eng●pmda.go.jp

Note:
For the purpose of security, this email address is partly incorrect. Please replace ● with @ when sending an email.

Related Information

• Columns (Chemical drug)

 

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.