I don't need the full ADE report. Just provide me the ADE value.

Here at Affygility Solutions we often get requests to provide just the ADE value without providing the fully-documented health-based exposure limit (HBEL) report. The reason for these requests are so the customer can insert the value(s) into their cleaning validation matrix and make the determination of which product(s) represent the worst-case from a cleaning scenario.

While we understand that companies try this approach in order to save money; unfortunately, we are unable to respond to these requests since it would cause a significant non-compliance finding with the EMA, WHO, ANVISA, Health Canada and PIC/S requirements. These requirements and expectations from the regulatory agencies are as follows:

From the PIC/S' QUESTIONS AND ANSWERS ON IMPLEMENTATION OF RISK-BASED PREVENTION OF CROSS CONTAMINATION IN PRODUCTION AND ‘GUIDELINE ON SETTING HEALTH-BASED EXPOSURE LIMITS FOR USE IN RISK IDENTIFICATION IN THE MANUFACTURE OF DIFFERENT MEDICINAL PRODUCTS IN SHARED FACILITIES

From the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.

Additionally from the PIC/S AIDE-MEMOIRE INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL) ASSESSMENTS AND USE IN QUALITY RISK MANAGEMENT.

It is important to remember that having just the ADE value without a fully-documented HBEL report prepared by a qualified toxicologist does not meet regulatory requirements.