Pharmaceutical Technology Europe - October 2010 - (Page 7)

Validating single-use systems There are a number of validation approaches that can be adopted — all of which incorporate the established approach of user requirement specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Validating single-use systems, however, requires a few changes of emphasis with respect to these specific steps. For single-use systems in general, validation can be performed in three areas. The first relates to the actual process operation itself. This will be dependent on the intended use, e.g., aseptic operations, short- or long-term product hold, etc. A risk-based approach will determine the validation programme based on the end use and process requirements. Secondly, it may be necessary to validate the manufacturing process for the single-use components and the quality assurance systems applied by the supplier. Finally, the actual supply chain process of the single-use system and the stability of the supply chain must be evaluated. to vendor audits where the entire operational and QA systems of the selected supplier will be appraised. In particular, detailed assessments of operational procedures, including system assembly and the training of associated procedures will be required. This is where the highest risks are likely to lie in terms of operational errors and failed batches. PTE Key points to consider The key consideration for the validation of single-use systems is the recognition that much of the ownership of the quality systems will lie with the selected system’s vendor. If the systems are part of standard packages, then this will also need to be factored into the validation approach. The use of the single-use systems also places much greater emphasis on the operators responsible for conducting system assembly procedures and, in most cases, there will be a reduced capacity to verify systems ahead of manufacturing operations. Under these circumstances, IQ is required Tony Hitchc ock every time a system is used and the validation approach needs to take this into consideration. Assessment of OP and staff training is also required to accommodate the change in process risk. Over and above validating the fixed plant and the process, the programme will also involve reviewing operational procedures — many of which will be performed at a remote, third-party site. As such, the validation process will need to be more extensive with respect Based on contributions by Tony Hitchcock, Head of Manufacturing Technologies at RecipharmCobra Bio, and George Saunders, Validation Manager at RecipharmCobra Bio. To read the full version of this article, go to www.pharmtech.com/thitchcock www.recipharm. 1 CONTENTS 8 MATERIAL COMPATIBILITY 3 HARNESSING THE ADVANTAGES 10 SINGLE-USE BIOREACTORS 6 CMO ADOPTION 11 QUALITY AGREEMENT TEMPLATE 7 VALIDATION 12 TOP TECHNOLOGIES http://www.pharmtech.com/thitchcock http://www.recipharm.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - October 2010

Table of Contents
Pharmaceutical Technology Europe - October 2010
Our Survey Says...
Harnessing the Advantages of Single-Use Systems
Should You Implement Single-Use Systems?
CMO Industry Adoption of Single-Use Technology
Validating Single-Use Systems
Material Compatibility and Single Use Systems
Achieving More Effective Cell Culture with Single-Use Systems
The Pros and Cons of Single-Use Bioreactors
Developing a Quality Agreement Template for Single-Use Systems
Ten Top Single-Use Technologies Showcased

Pharmaceutical Technology Europe - October 2010