• Manoj Swaminathan

Change Controls - Effective project management tool!

Updated: Aug 11

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 important aspects.

Whenever there is a new product acquisition or approval (unless initiated at the time of filing the new application), there may be a series of activities that need to follow, and not limited to:

  • PSMF update

  • BCP

  • Literature monitoring list inclusion

  • Website update

  • Safety Database configuration

  • Article 57 update

  • SDEA update

  • Medical information Q&A or training

  • Training Pharmacovigilance team

  • L2A/ MLM impact

  • Integration into PQC management life-cycle

  • RMP impact, etc etc

Given the fact that none of these activities can be afforded missed by the PhV team, it may be convenient to track using a change control. One can have pre-defined change control checklists in the QMS, so as to improve efficiency.

While introducing a new distributor/ business partner/ SDEA partner, change control with all action points will ensure adequate PhV compliance.

In the case of M&A, change controls are extremely effective. This is irrespective of the complexity of acquisition, where a checklist considering all the parameters will be useful.

It is generally the Pharmacovigilance team that generally raises the change control for its function. In some quality-conscious companies, it is generally the corporate quality team that raises the centralized change control for new product introduction where PhV is also included. One may argue that this is the ideal scenario, however, depending on the size of the company and quality culture, this may be handled differently.

To conclude, effective utilization of change control is useful in ensuring PhV compliance. Having a good QMS system will also ensure that the action items associated with the change control are completed in a timely manner.