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Microorganisms, too embarrassed to ask others about！（Part 14）

In this part, I would like to describe sterilization. Sterilization is employed widely in the drug product and medical device industries. You may have

China NMPA’s observations of ‘flight inspection’ on medical devices

In 2023, the China NMPA(National Medical Products Administration) conducted ‘flight inspections’ (unannounced inspections) to 20 medical d

Microorganisms、too embarrassed to ask others about！（Part 13）

5.5 Raw Materials, and Labeling and Packaging Materials <Notes> 1. Since most raw materials and materials are purchased from outside sources, t

Microorganisms、too embarrassed to ask others about！（Part 12）

5.1 What Microorganisms Like/Dislike In principle, every kind of microorganisms from bacteria, fungi to viruses are the subjects for microbiological c

FDA's Criticized Overseas Inspection Program

FDA's Criticized Overseas Inspection Program

The U.S. House of Representatives Committee on Energy and Commerce oversees the FDA's foreign drug inspection program. Members of the Committee h

PMDA ORANGE LETTER_2023.10

ORANGE LETTER Author: PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER Issue: October 2023 Title: Communication within the orga

Microorganisms、too embarrassed to ask others about！（Part 11）

4.1 Extermination with Heat We have two major approaches to exterminate microorganisms with heat: heating under the condition where water exists (mois

FDA's Criticized Overseas Inspection Program

FDA's Criticized Overseas Inspection Program

The U.S. House of Representatives Committee on Energy and Commerce oversees the FDA's foreign drug inspection program. Members of the Committee h

PMDA ORANGE LETTER_2023.7

ORANGE LETTER Author: PMDA Observed Regulatory Attention/Notification of GMP Elements LETTER Issue: July 2023 Title: Handling of results related to s