Category Archives: Blog Archive

Data Integrity Concerns Involving Pfizer’s Vaccine

“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…
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ICU Medical, Inc. Amino Acid Injection Recall

Particulate matter was found in an Amino Acid Injection in September.  ICU Medical, Inc. voluntarily recalled one lot of Aminosyn II, 15% of 2,112 units.  This is a Sulfite Free IV solution used in hospitals.  The recall was enforced due to particles such as fibers, hairs and proteinaceous materials.  These particles were found when ICU…
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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…
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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…
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