<br/>The Challenges Most Face

Creating a Holistic Contamination Control Strategy (CCS)

You need to be able to monitor and reduce particulates and microbiological contaminants, assure sterility and work towards the use of barrier technologies. Are you ready to implement these changes?

Effectively Maintaining Container Closure Integrity (CCI)

You need to have a robust understanding of the factors impacting CCI so that you can monitor and test each factor over the life of the drug product. Are your processes set up to do this?

Extractables and Leachables (E&L) is a New Inclusion

E&L have both direct and indirect impacts on product quality and patient safety as the extractable could be toxic and impurities could interact with the drug product. How will you manage E&L to address product quality impacts?

Four Key Considerations When Assessing Components for Annex 1 Readiness

1

Product: Component Specifications​

What are your current component quality specifications for particulates, bioburden and endotoxins? Do they need to be tighter?

2

Process: Manufacturing Design

How will your components and finished drug product be sterilized? How will your components be introduced to the fill/finish line?

3

Protection: Container Closure Integrity

Do you fully understand the multiple factors affecting CCI? What monitoring and testing plan is in place over the drug product shelf life to ensure sterility?

4

Proof: Documentation & Service

Does your supplier have a holistic CCS focused on continual improvement? What documentation is available to support your CCS?

Learn about Annex 1, CCS and CCI From These Resources
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EU GMP Annex 1 regulations and standards

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