pharmaphorum

JUNE 22, 2023

Challenges of analytical method validation for ATMPs Mike.Hammerton Thu, 22/06/2023 - 08:00 Bookmark this

Method Validation 98

Method Validation 98

European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

Method Validation 91

Method Validation Documentation FDA 91

ISPE

JUNE 2, 2023

reduce non-value-added tests) Contract lab management Reference standards & critical reagent management Rapid micro testing Training (e.g.,

Method Validation 98

Method Validation 98

ISPE

MAY 10, 2023

CoP Leader Profiles: Roujian “RJ” Zhang Trudy Patterson Wed, 05/10/2023 - 11:37 InTouch May / June 2023 CoP Leader Profiles: Roujian “RJ” Zhang Marcy Sanford 1 May 2023 Roujian “RJ” Zhang is Chair of ISPE’s new Quality Control (QC)/Analytical Community of Practice (CoP) Steering Committee.

Method Validation 52

Method Validation FDA 52

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

European Pharmaceutical Review

MARCH 6, 2024

Additionally, the new laboratory offers Ariceum the ability to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds. Internet] European Pharmaceutical Review, Issue 3 2023. 1 References Jaafar-Thiel. cited 2024Mar].

Method Validation 92

Method Validation Compounding 92

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

FDA 91

FDA Documentation Method Validation Packaging 91