A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH Q14 guideline Analytical Procedure Development and the revision of Q2(R1) Analytical Validation.
Stability by Design - Guidelines for Assessing & Controlling Physical Stability
The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms.
The USP posted a new timeline for the implementation of the plastics packaging chapters 661.1 and 661.2. So far, the new chapters were to become applicable on May 1, 2020. The implementation of the new requirements will now be delayed until December 1, 2025.
FDA Warning Letter: Outlier Test inadequate for OOS Investigation
The API manufacture Zhuhai United Laboratories Co. Ltd. received a Warning Letter from the FDA in June 2018. The FDA criticized that the OOS results of assay determinations haven't been adequately investigated. According to the FDA, the sole use of outlier tests is not appropriate. Read more about FDA's Warning Letter to Zhuhai United Laboratories.
Missing Investigation of OOS Results leads to FDA Warning Letter
The API manufacturer Keshava received a Warning Letter from the FDA in March 2018. During the inspection, it has been criticised that no corrective actions had been taken for Out-of-Specification results and that a few analyses missed complete data. Read more here about the FDA Warning Letter for Keshava Organics.
USP Stimuli Article on the Correct Use of Mean Kinetic Temperature
Recording temperatures during transport of pharmaceutical products as well as calculating the mean kinetic temperature is essential for assessing a batch with regard to its quality status. How to avoid mistakes when calculating the mean kinetic temperature?
Insufficient handling of data integrity and validation of analytical methods lead to FDA warning letter
Drug manufacturer Reine Lifescience received an FDA warning letter in May 2018. During the inspection, it was particularly criticised that the company could not provide data on the validation and verification of their analytical methods. The controls of their computerised systems have not been sufficient, either. Read more about the recent FDA warning letter to Reine Lifescience.
How should modern analytical development be conducted?
The board of the ECA Foundation's "Analytical Quality Control Group" wants to strengthen the lifecycle approach to analytical development. Therefore, the Group developed a new guideline on "Analytical Procedure Lifecycle Management". Find out more about the content of the new APLM Guideline and on how modern analytical development should be conducted today.
FDA warning letter due to non-compliance with specifications and ID testing
Drug manufacturer IDT Australia Ltd. received an FDA warning letter in May 2018. It was criticised during the FDA inspection that OOS results of assay determinations had not been investigated and that a batch had been released even though three consecutive identity tests had failed. Read more about the IDT Australia FDA warning letter here.
Revised FDA Guidance on the validation of analytical methods
After five years and thorough revision, the FDA Guidance "Bioanalytical Method Validation" has been finalised. Read here what requirements the FDA lays down for a completely validated bioanalytical procedure.