The Indian pharma industry is on a good growth path and is likely to be in the top 10 global markets by value by 2020. High burden of disease, good economic growth leading to higher disposable incomes, improvements in healthcare infrastructure and improved healthcare financing are driving growth in the domestic market. Pharma companies are […]
Now a day’s regulators looking for control on the product /system recipe. Recipes are very critical part of process. Because process are control through validated recipe. If firm calming that their system complying 21 CFR par 11/EU annex 11, in that case they should ensure that their system is capable for following mentioned control, […]
New era of Indian Pharmaceutical industry is going to begin. Major regulatory pharmaceutical companies are under USFDA alert. Repeated/similar observation are reported against data integrity and GMP practices. Now a day’s process are dependent on the human being, however transition from human to automation is very high. But it is not like that automation can […]
One of the most critical operations in pharmaceutical manufacturing is the processing of sterile products. The production of sterile products, specifically the ones that cannot be terminally sterilized,involve complex and demanding processes to prevent the products’ contamination and require a great amount of resources. The objectives of review includes: Obtain information on operations impacting on […]
Few facts about Dynamic Pass Box Through this blog we will be providing you the qualification and routine maintenance of dynamic pass boxes in your critical and non critical area. As per the industrial practices some time we do more than the requirement and that create an additional burden for us. Rather than doing extra […]
1. What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year. Is the same frequency expected of a process conducted in an isolator?A firm’s justification for the frequency of media fills in relation to shifts should be risk […]
Figure: Aseptic filling operation Assessment made based on the FDA 2004 Aseptic guidance: 1. Initial clean room qualification includes, in part, an assessment of air quality under as-built, static conditions. A. True B. False 2. Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations would be of appropriate particle quality when […]
Process simulation studies (media fills) are simulating the whole process in order to evaluate the sterility confidence of the process. Process simulation studies include formulation (compounding), filtration and filling with suitable media. Simulations are made to ensure that the regular process for commercial batches repeatedly and reliably produces the finished product of the required quality. […]
Air pattern or “smoke” studies demonstrating laminarity and sweeping action over and away from the product under dynamic conditionsshould be conducted. The studies should be well-documented with written conclusions. Videotape or other recording mechanisms have been found to be useful in assessing airflow initially as well as facilitating evaluation of subsequent equipment configuration changes. However, […]
Now a days the topic “Data integrity and non compliance” is the hot topics. Lots of references available online that deals with the Data integrity issue. One of the major example am going to give today, that can be control by the management only. Extended shift/working hour or over time:We know that “Human error” is the […]
