Cross-contamination Risk Assessment in Pharmaceutical Manufacturing MasterClass - EU edition

This training summarizes the current regulatory requirements to perform a structured assessment of cross-contamination risks and presents an approach how this can be implemented in practice.

07-08 December, 2023, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

It is common practice in the Pharmaceutical Industry to manufacture multiple drug products in shared facilities with shared equipment. To avoid cross-contamination, all surfaces with product contact are cleaned prior to manufacturing of the subsequent product. According to current EU GMP requirements, the cleaning process has to be validated taking into account the API specific PDE (“Permitted Daily Exposure”) values. The EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” finalised 2014 and a Q&A paper published by the EMA in 2018 deal with the topic of cross-contamination and going far beyond cleaning validation. The Aide-Memoires PIC/S PI 043- 1 and PIC/S PI 046-1 published in 2018 are setting common standards for Authority audits. The auditors should assess if a pharmaceutical company has implemented adequate processes to systematically assess and mitigate product- and process-related risks for cross-contamination. The entire process chain from material entry to sampling, dispensing, manufacturing and product dispatch has to be assessed taking into account the 4 basic possibilities of cross-contamination:


Retention
Airborne transfer
Mechanical transfer
Mix-up


Authority inspectors are including these aspects in the focus of their audits and check if companies have implemented well-structured and adequate risk management systems to deal with cross-contamination. This training summarizes the current regulatory requirements to perform a structured assessment of cross-contamination risks and presents an approach how this can be implemented in practice.

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RECOMMENDATION

Who should attend?

• Manufacturing Heads
• Heads of QA
• Heads of QC
• Manufacturing Managers
• QA Managers
• QC Managers
• Pharmaceutical Development Heads
• Technical Directors