Will your company be affected by the new Draft EMA guidelines on avoiding cross-contamination of products made in shared facilities? Some pharmaceutical manufacturers and CMOs may have to revisit their cross-contamination risk assessments and revalidate their cleaning procedures.
According to the EMA website, reviewed in the March 2013 issue of Bio/Pharmaceutical Outsourcing Report, the new draft offers suggestions on how companies may best comply with GMP revisions designed to prevent residual APIs from one product contaminating another, potentially placing patients at risk. Joachim del Boca, vice president of regulatory affairs/quality compliance at Vetter offers insight into the regulations as they affect cleaning processes and, in particular, as they apply to the entire cleanroom not just the equipment in direct contact with substances. Mr. del Boca offers suggestions on how companies may have to intensify their cleaning procedures in light of the new guidance.
New approach to cross-contamination prevention in EU provided in draft guidelines
BioPharmaceutical Outsourcing Report, PharmSource, page 8