qms

The Pharmacovigilance function is required to have a robust Quality Management System (QMS) and for this, one needs to have efficient standard operating procedures or SOPs. Apart from the SOPs, one can consider other documents, such as working practices (work instructions) or guidelines/guidance documents, as recommended in the QMS of the organization. The list of […]

I know this looks like a very basic topic and may not interest everyone working in the field of Pharmacovigilance. However, please note that numerous companies in developing countries (including the highly populated ones) may not have any Pharmacovigilance department. One of the main reasons why these companies hesitate to create one is because setting […]

Quite often in Pharmacovigilance department, you would find people who get annoyed upon hearing terms such as deviation, CAPA and change controls. If utilized properly, change control can serve as an effective project management tool. Considering the dynamic nature of the Pharmaceutical business, it is essential that the Pharmacovigilance department does not miss out on […]