Category: Uncategorized
A tale on Planet of Earth on Racial Distinguishes
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 […]
Guidance on Gloves maintenance in Isolator and RABS
A faulty glove or sleeve assembly represents a route of contamination and a critical breach of Isolator integrity. Within this article we will discuss about all these aspects. Click here to read more
Tips for Successful FDA Audit
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Compliance to regulatory requirements in Pharmaceutical industries
Current regulatory inspection is come up with lots of recommendations. In this article will be discussing regarding the different regulatory requirements. This is the time to evaluate our existing procedure and mitigating the risk. Here will discuss about the recommendation which received different regulatory authority. Keep your eyes to our blog and check whether you […]
Recipe control in manufacturing system
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, […]
Media fill FAQ
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 […]
Use of Nitrogen gas in lyophilizer during media fill
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. […]
Regulatory guidace on Smoke study
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, […]
Label Control
Overview Controlling the storage and issuing of labels and labeling helps prevent mix-ups. Technology, such as bar-codes and vision systems, has reduced the number of label – related recalls, but controlling label storage and issuance is still very important. General Precautions 1. When setting up a program for the packaging operations, particular attention should […]