GMP Webinar: Stratified Sampling - What is state of the art regarding the validation of blend uniformity for solids?

GMP Webinar: Stratified Sampling - What is state of the art regarding the validation of blend uniformity for solids?

Course No 16552


Costs

Non-ECA Members: EUR 199,--
ECA Members: EUR 149,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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.

Background

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 Based on a PQRI recommendation, FDA published in 2003 the Draft Guidance “Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment“.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was never finalized, it represented the state of the art regarding blend uniformity testing until 2013 when it was withdrawn by FDA.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.

Target Group

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.

Programme

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?

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK