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 […]
Understanding and analysis of Equilibration Time will tell, how your cycle is consistent. Recently an article in PDA journal (1) was published to understand the impact of the following autoclave variables on the consistent measurement of the equilibration time and on the reduction of the equilibration time. Based on the all demonstrated study in the […]
This article is based on the practice experience gained by performing hundreds of validation test conducted on the dozen of steam sterilizer of various manufacturer. It is primarily intended that personnel who performed validation testing on steam sterilizer may benefit from these experience, and that it will assist in ensuring a high level of compliance […]
For Grade A zones, particle monitoring should be undertaken for the full duration of critical processing, including equipment assembly, except where justified by contaminants in the process that would damage the particle counter or present a hazard, for example, live organisms and radiological hazards. In such cases monitoring during routine equipment set-up operations should be […]
A Review Article on Visual Inspection program for sterile injectable product- A complete solution for manual inspection process
For companies registered with the FDA, you can check the FDA’s inspection database to see the specific firms compliance status (NAI, VAI, or OAI) – https://www.fda.gov/iceci/inspections/ucm222557.htm. I prefer starting here as it gives me a picture of their status over time. You can also go to the FDA ORA FOIA electronic reading room and can find […]
