Wholesale Distribution - Post Re-regulation

In concordance with the re-regulated market for wholesale distribution of medicinal products in Sweden, new requirements for retail traders were introduced on July 1st 2009. Are your quality management system adjusted to the new requirements?

The new set of regulations includes:

• Business- and Quality Management System
• Documentation practices to ensure audit trailing
• Facilities and equipment that are adequate for their specific use; storage areas with monitored temperature and calibrated control equipment
• Validated computerised systems
• Staff trained in relevant sets of regulations, i.e. Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and LVFS 2009:11.

A quality management system is a pre-requisite for good quality work.

We have many years experience of working with quality assurance issues within the pharmaceutical industry. On a daily basis, we work with different sets of regulations and their interpretations and thus, we can use this experience to assist you in complying with the requirements in the new set of regulations.

Allow us to help you upgrade your quality management system according to LVFS 2009:11!