Faster cleaning validation in pharma plants

摘要

All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive, disposable systems exclusively. Using the latitude available in current good manufacturing practices for the 21st century, scientific data evaluation and risk-based approaches can streamline the process. By developing sound and defensible programmes with rapid and specific testing, cleaning validation can be more efficiently and effectively implemented.