Sprecher
Dr Gerrit Hauck, Basilea Pharmaceutica International AG, Basel
Dr Gerrit Hauck is Chief Technology Officer at Basilea overseeing the company’s technical development and commercial manufacturing activities. Before that he hold different positions in technical development at Sanofi-Aventis Deutschland GmbH.
Hintergrund
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 Based on a PQRI recommendation, FDA published in 2003 the Draft Guidance “Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment“.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was never finalized, it represented the state of the art regarding blend uniformity testing until 2013 when it was withdrawn by FDA.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.
Zielgruppe
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.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.htm you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
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?
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