“We are operating at the speed of science.”, Albert Bourla stated when sharing news about the Pfizer’s vaccine in manufacturing sites in Texas. With the need of these vaccinations, some testing sites in Texas tried to speed up the process and distribute as many products as they could—leading them to go against data integrity and…Read more
Is Your Sterile Injectable Ready for Changes in Raw Materials?
In any manufacturing company, it is likely that raw material will change from time to time. These changes are modifications in API synthesis, key starter materials and intermediates. These changes are expected and necessary for manufacturing improvement. The best approach to alternating materials from a supplier, is to always keep track and maintain data and…Read more
Is your Equipment Qualified?
The slightest error or misuse of equipment could lead to an expensive risk, delay manufacturing of a product and minimize the amount of sales. It is necessary to have all items involved in the manufacturing process go through a qualification test. Equipment qualification is extremely critical. Qualification needs to be documented and recorded for both…Read more
Robotics, Isolators & Restricted Access Barrier Systems
Aseptic Process is the process for manufacturing sterile products where microbiological contaminants could not enter the production area or surface of the product. It is challenging for pharmaceutical manufacturers to ensure that the product they are handling will have absolutely no contaminants—especially if involving parenteral drugs. To isolate human contamination, it is beneficial to use…Read more