Cross Contamination The new EU requirements for the use of multipurpose equipment

Objectives

This GMP training course aims at unveiling possible risks of cross contamination during the production process of pharmaceutical products and APIs. This is especially important as chapters 3 and 5 of EU GMP Guideline are being updated at the moment, with a new focus on the avoidance of cross contamination

Learn

• how to detect possible risks,
• how to avoid cross contamination,
• how to determine exposure limits

Background

Cross Contamination is one of the highest risks for patients using pharmaceutical products. Not only the presence of small amounts of antibiotics or other highly potent compounds in medicines can cause severe damage but also carryover of products into another pharmaceutical product is of high risk to the patient. According to the Medicines & Healthcare Products Regulatory Agency in the United Kingdom Product contamination is the second to third highest reason for recalls in the UK in recent years.

Cross Contamination is one of the highest risks for
patients using pharmaceutical products. Not only the presence of small amounts of antibiotics or other highly potent compounds in medicines can cause severe damage but also carryover of products into another pharmaceutical product is of high risk to the patient. According to the Medicines & Healthcare Products Regulatory Agency in the United Kingdom Product contamination is the second to third highest reason
for recalls in the UK in recent years.

It is therefore not surprising that the EU commission published an update of the chapters 3 (premises & equipment) and 5 (production) with the focus on minimizing the risk of cross contamination. Almost at the same time a new EMA Guide on setting health based exposure limits was published. This new guide has massive impact on the dedication of facilities and also on the calculation of limits for cleaning validation. The currently used 1/1000 dose or 10 ppm criteria will become completely obsolete.

Reasons for cross contamination can be manifold and caused by technical as well as organisational deficiencies. Insufficient cleaning of equipment, poor facility design or inappropriate design of the HVAC system may be reasons as well as contamination due via personnel or primary packing material. But also the design of the production process itself can be the cause for cross contamination, for example due to open product handling during transfer or sampling operations in shared plants.

It is therefore extremely important to avoid or minimise the risk of cross contamination, starting when process and equipment are designed. It is also important to learn how contamination risks can be detected, either by visits on-site or by reviewing of the documents which can be SOPs or technical drawings.