Second Revision of USP Chapter <1> Injections and Implanted Drug Products (Parenterals)-Product Quality Tests

Recommendation
13/14 May 2025
GM Requirements for Planning, Qualification and Operation
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
23.04.2025Data Integrity Violations at an OTC Manufacturer
23.04.2025Warning Letter to Indian API Manufacturer due to Restricted Access
16.04.2025Warning Letter to Chinese API Manufacturer
09.04.2025GMP Violations by Chinese OTC Manufacturer
26.03.2025Pharmaceutical Construction Sites: Dealing with Documents in Piping Construction
19.03.2025New VDI Guideline 6022 Blatt 8.1 - Cleaning of Ventilation and Air-Conditioning Systems