recorded on 18.10.2017
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Validation of blend uniformity is one of the critical steps in process validation for solids. Whereas in Europe there is no regulatory requirement with regards to the validation of blend uniformity, this is different in the USA. The 21 Code of Federal Regulation (CFR) 211.110 requires pharmaceutical manufacturers to demonstrate the adequacy of their mixing operations on a routine basis. Due to issues with sampling of powder blends, this topic is under discussion since the early 90s. Based on a PQRI recommendation, FDA published in 2003 the Draft Guidance “Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment“. This document described stratified sampling as method for the validation of the blend uniformity and proposed a sampling plan for final product testing. Although the guidance was never finalized, it represented the state of the art regarding blend uniformity testing until 2013 when it was withdrawn by FDA. Apart from sample size requirements the acceptance criteria for uniformity of dosage units no longer represented the agency’s „current thinking“.
What is today state of the art regarding the validation of
blend uniformity? The webinar will provide an answer to this question.
Addressed are following topics regarding the validation of blend uniformity from solids
PQRI proposal regarding Stratified Sampling
The FDA draft Guidance for Industry „Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit
Sampling and Assessment“ Why did FDA withdraw its draft guidance?
How relevant are the ASTM standards 2709 and 2810 for the FDA?
What is the impact of sample size on the test characteristic?
Does ISPE´s proposal „Recommended Changes to Withdrawn FDA Draft Stratified Sampling Guidance Document“ close the gap?
What is accepted by the FDA today?
The webinar targets employees who are involved in the validation of solids and want to know what is state oft he art regarding the validation of blend uniformity, e.g. head of production, head of validation, members from Quality Assurance departments.
Dr Gerrit Hauck, Sanofi-Aventis Germany GmbH, Frankfurt/M.
Dr Gerrit Hauck has joined Sanofi-Aventis Deutschland GmbH in 1993. Since then he headed different positions within galenical, scale-up and technical development departments. Currently he is head of the cluster Synthetic Molecules for Sanofi and is responsible for the technical project leaders, who manage the development projects for synthetic molecules, peptides and oligonucleotides.