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Regulatory Focus™ > News Articles > 2020 > 6 > PIC/S adopts cross-contamination, HBEL guides

PIC/S adopts cross-contamination, HBEL guides

Posted 05 June 2020 | By Michael Mezher 

PIC/S adopts cross-contamination, HBEL guides

Following their adoption last month, two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents entered into force this week, a questions and answers guidance on implementing risk-based prevention of cross-contamination and an aide-memoire on health-based exposure limit (HBEL) assessments.
 
Both documents were adopted on 22 May 2020 following development and review by the PIC/S Expert Circle and entered into force on 1 June 2020.
 
The first of the two documents, 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,’ is based on and transposed from the European Medicines Agency’s (EMA) guideline of the same name.
 
The document fully mirrors the EMA version, which itself was adopted in 2018, except for an added references section that points to other PIC/S guides. (RELATED: EMA overhauls manufacturing cross-contamination Q&A after industry savages draft, Regulatory Focus 9 August 2018).
 
The second document, which references both the HBEL guide and Q&A, is “describes an approach to assessing HBEL that can be conducted by inspectors without specialised toxicology knowledge.”
 
“Inspectors should be aware that HBEL assessments are an interpretation of available data and application of adjustment factors assigned through expert analysis. However, there can be differences in the use of data that can result in variation in HBEL values between assessments of the same substance by different experts,” the document notes, adding that three-fold variations in values are typical and that at or above 10-fold should be investigated.

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