Good Manufacturing Practices (GMP) Deficiencies at Ben Venue Laboratories Inc, USA

Pfizer, in consultation with the Health Sciences Authority (HSA) would like to update healthcare professionals on the GMP deficiencies identified at Ben Venue Laboratories Inc. (BVL). The recent EMA inspection of BVL's manufacturing facilities resulted in observations relating to deficiencies which may potentially affect product quality, including the presence of particulate matter in certain products. Among the products manufactured at BVL includes the diluent for Pfizer's product, Torisel. The recommendations to healthcare professionals include to visually inspect the Torisel diluent vials in order to ensure the absence of particulate matter before dilution and administration of the reconstituted medicinal product, in order to minimize relevant risk.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.