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Notice on the public solicitation of opinions on the "Technical Guidelines for the Study of Microbial Limits of Non-sterile Chemicals and Raw Materials (Draft for Comments)"

 Last Update: 2022-10-19
 Source: Internet
 Author: User

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Notice on the public solicitation of opinions on the "Technical Guidelines for the Study of Microbial Limits of Non-sterile Chemicals and Raw Materials (Draft for Comments)"

Release date: 20221010

In order to further strengthen the application of quality risk management in product quality control, improve the scientific and rationality of the formulation of microbial limit standards for non-sterile chemicals and raw and auxiliary materials, and clarify the relevant requirements for microbial limit research and control in the declaration materials, our center organized and drafted the "Technical Guidelines for the Study of Microbial Limits of Non-sterile Chemicals and Raw Materials (Draft for Comments)"
after research and discussion with experts and the industry.

We sincerely welcome valuable comments and suggestions from all sectors of the community on the consultation draft, and give us timely feedback for follow-up improvement
.
The time limit for soliciting comments is 1 month
from the date of publication.

Please send your feedback to the email address
of the following contact person.

Contact: Li Shanshan; ZHAO Lei; Wang Weiping

Email: lishsh@cde.
org.
cn;zhaolei@cde.
org.
cn;wangwp@cde.
org.
cn

Thank you for your participation and great support
.

Center for Drug Evaluation

October 10, 2022

Related attachments

serial number	Attachment name
1	Technical Guidelines for the Study of Microbial Limits of Non-sterile Chemicals and Raw Materials (Draft for Comments). . docx
2	The drafting notes of the Technical Guidelines for the Study of Microbial Limits of Non-sterile Chemicals and Raw Materials (Draft for Comments) are . docx
3	The feedback form of the "Technical Guidelines for the Study of Microbial Limits of Non-sterile Chemicals and Raw and Excipients (Draft for Comments)" is . docx

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