Second Revision of USP Chapter <1> Injections and Implanted Drug Products (Parenterals)-Product Quality Tests
Recommendation
28/29 January 2025
Generation, Monitoring & Compliance
Register now for ECA's GMP Newsletter
Last year already, the revision of the General Chapter on quality testing of sterile medicinal products was initiated in the USP 38 NF 33. The targeted official date for coming into force was the 1st May 2016. Now, the USP has announced that because of some comments received, there will be a further revision. This is due to the USP's intention to support in Chapter 1 both existing monographs as well as new monographs to be developed. The new scope should now be focussed again to avoid confusion. The publication is striven for March 2016 as well as the adoption of the changes in the USP 40 NF 35. Furthermore, USP has announced that also the contents of General Chapters <2> to <5> will be examined.
On the USP website you will find further details regarding the revision of Chapter <1>.
Related GMP News
06.11.2024FDA Warning Letter to a US Manufacturer of Medical Gases
30.10.2024WHO Guidance on Wastewater and Solid Waste Treatment in the Antibiotics Production
23.10.2024Warning Letter to Indian sterile Manufacturer due to Cross-Contamination and Particles
16.10.2024Do Parenterals have to be 100% free of Particles?
02.10.2024Does Purified Water have to be tested for Endotoxins?
18.09.2024FDA issues Warning Letter to Cell Gene Therapy manufacturer