Recall/Notifications

The continued safety of the plasma protein product is maintained post marketing through routine pharmacovigilance activities called Good Pharmacovigilance Practices (GVP). Documentation related to the following is a regulatory requirement as part of the GVP for plasma protein products.

A. A procedure to record all complaints

B. Adverse Drug Reaction (ADR) receipt, evaluation and reporting procedures

C. Published literature and databases must be searched regularly for any ADR’s reports for the marketed drug

D. Preparation of Annual Summary Report listing any and all information related to ADRs and serious ADRs over the last 12 months

E. Receipt and reporting procedures for failure in efficacy of the drug