Only 2 years left…

Have only two years to prepare for FMD compliance.  EU FMD specifically outlines how the EU will track and trace medications using serialisation, government reporting, and verification components. This time last year (February 2016) the Delegated Act was published on...

Need Bona Fide help?

Having trouble gathering all the necessary information about your customer or supplier? Getting ready for Inspection? Short of time? Having difficulties? PCL have many years of experience in bona fide checks. We offer different levels of help: Bespoke Bona fide Team...

Outsourced Activity

Product quality is the responsibility of all parties involved in the development, manufacturing, testing, packaging, distribution and regulation of materials that make up the clinical or commercial drug product. “outsourced should be appropriately defined, agreed and...

Recall – drug

Important to have a robust procedure for handling recalls. Have you tested your “recall” system? What will you do with the recalled product?  Here are a few points to consider about your process: Set out responsibilities: recall, traceability and approval duties....