WHO Guidelines on the Transfer of Technology in the Pharmaceutical manufacturing
A new draft guideline has been released by WHO in April 2021 for public review and comments. In this guideline there is a detailed procedure has been described for quality control analytical procedure transfer where in the responsibilities of transfer laboratory and receiving laboratory has been provided in details. You an access this guideline by clicking the link WHO - Transfer of Technology - Draft.
International pharmacopeia is available online freely for use
You can access through this link Int. Pharmacopeia online.
USP - Pharamacopeial Update
To know more about the recent update on USP pharamacopeial forum click USP PF.
USP chapter <1095> Batch release testing for ensuring compliance with uniformity dosage unit has been published for public comments.- PF 47(4)
USP chapter <1099> Limit on number of large deviations when assessing the content uniformity for large samples - PF(4)
USP chapter <781> Optical Rotation and <831> Refractive index has been revised and published in pharmacopeial forum PF 47(3) for public comments
An assessment report has been released by EMA for control of Nitrosoamine impurity in sartans containing tetrazone group.
Control of Nitrosoamine impurities in APIC has published for template for report on the risk of potential presence of Nitosoamine impurities. it can be accessed through this link APIC - Nitrosoamine
Ph_Eur has newly introduced 2.5.42 - N-Nitrosoamine in active substances. Read more