Pharmaceutical Resource & Education Services

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

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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…

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…

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…

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…

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…

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…