There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary. A broad issue for single-use filter users ...

At different stages of the drug lifecycle, the minimum provision for parenteral products is a safety barrier against potential contaminants. This protection is guaranteed by selected container closure ...

New FDA guidance developed to identify lapses in data integrity and promote best practices. With data integrity identified as a primary focus of its enforcement actions, FDA issued a new guidance ...