The words “plant shutdown” — even if referring to a temporary one — can be associated with a long litany of negatives. Stopping production, no matter the duration, results in decreased revenue. The additional resources and other costs associated with the shutdown make it a very expensive endeavor. Most shutdowns are highly complex and carry […]
Vaccines are a group of pharmaceuticals that include some of the oldest biologically-made compounds. The Smallpox vaccine was introduced by Edward Jenner as early as in 1796 and Louis Pasteur created the first live attenuated bacterial (Chicken Cholera) and viral (Rabies) vaccines at the end of the 19th century. A vaccine contains an antigen that […]
What is infection? The invasion and multiplication of microorganisms such as bacteria, viruses, and parasites that are not normally present within the body. An infection may cause no symptoms and be subclinical, or it may cause symptoms and be clinically apparent. An infection may remain localized, or it may spread through the blood or lymphatic […]
When the bioburden method is employed for sterilization process, the bioburden trend of materials and products should be routinely and frequently monitored and, if more heat-resistant microorganisms are identified, then method should re-validate and the potential effect of the microorganisms on pharmaceutical products already shipped from the plant need to be evaluated to ensure patient […]
Remdesivir is an experimental drug from drug maker Gilead that has shown to bring down the viral load on patients and hence help in faster discharge. The efficacy of the drug on severe patients is still under study. The drug, intravenously administered in hospitals, has already been approved for emergency use in severely-ill patients in […]
We human being are categories under discrete variable from ancient with different peculiar attributes. We always categories our society with white and black, rich and poor, strong and weak, good and evil, literate and illiterate, other cultural differentiation like Islam, Christianity, Hinduism, Buddhism, Sikhism and many more. Human being is most intelligent creation by god […]
Certainly, hydroxychloroquine is in the peak news. Because Mr. President of USA commented in his official Twitter as well as press release also. Other countries also started following the same and looking for the medicine hydroxychloroquine. But let’s see what WHO recommending for this medicine, “1WHO is actively following the ongoing clinical trials that are […]
One of the key advantages of using an isolator for an aseptic processing application is that it makes a physical barrier between the operator and the core aseptic processing area. Additional main benefit is that an isolator can be totally sealed before aseptic activity starts, allowing for the exposed interior surfaces within to be bio-decontaminated, […]
“Fixing problem “is the main activity at pharmaceutical industry now a day. Rather than manufacturing medicine, we are focusing on the failure investigations, root cause identification, CA-PA implementation & effectiveness verification. When a facility or a product is designed, the risk based approach not followed. Maximum problems observed during tech transfer from R&D to commercial manufacturing. […]
The most important word in the pharmaceutical industry. Usually number of audit concluded based on the “What” and How? Few important examples are quoted below, What is the equipment requalification frequency? What is the HEPA replace frequency? What is the calibration frequency? Once you provide the reply of their next question will be, how you […]
