The pressure differential is the difference of the atmospheric pressure between the production area and its surrounding. It is measured in pascal using the magnetic pressure gauge.
This article covers general GMP procedures. Including QA staff must do a round of the plant area making sure that the plant adheres to the cGMP and fill up the checklist provided by the company. Head or In-charge personnel should review the plant audit and discuss this with the person in charge of the plant after which the audit report will be closed.
The process of sugar coating is rare in the pharmaceutical world recently. That said, knowing the problems that one can encounter would help in the event that sugar coating is needed and problems arise.
In sterile pharmaceutical preparations such as required for injectable dosage forms, the drugs are often supplied in glass vials. These should be cleaned before filling, and although automatic vial washing machines may be used to clean vials, it is important to have the cleaning process validated. The efficiency of the washing machine and process is verified by performing several tests, as follows.
Granulation is the process whereby powder forms are bound together to form aggregates, which are called as granules. Granulation is important as it helps prevent the separation of the ingredients in the mixture as well as improves the flow of the properties of the mixture. It also changes the size of the particles resulting to improved compression and density of the powder mix.