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.

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.