Pharmaceutical Controlled Area
The pharmaceuticals industry is meant to develop, produce and market drugs licensed for use in the medication of various diseases. For a drug to be approved to be used as a medicine, there is a need for the drug to pass certain quality checks. These checks are meant to ensure that what the pharmaceutical industry takes from the bench onto the shelves are drugs that are meant to cure or manage a specific condition and not poison.
The urge to have most of the drugs produced to be approved leads to the creation of controlled areas in pharmaceuticals. These leads to certain measures that create controlled areas in pharmaceuticals.Major pharmaceutical industries are keen to implement such measures in order to ensure they remain relevant in the competitive. Their survival depends on what they bring onto the shelves.
In pharmaceuticals, aseptic condition emerges as one of the controlled areas. The environment in which a drug is manufactured needs to be spotlessly clean in order to avoid the introduction of contaminants into the drug. The drugs being produced are supposed to be tested for microbial contaminants by the quality assurance team. This will ensure that those which are suspected of contamination are eliminated from the larger pack.
The dosage of the drug is also subject to control during the drug manufacturing process.As we need to know how much of the bio-active component of the drug is present in order to the device the appropriate dosage to the patient keeping in mind the pharmacokinetics and pharmacodynamics properties of the drug. The dosage of the drug can only be devised ones we know how the drug can be absorbed in the body, its distribution, metabolism, elimination and toxicity. A drug that is quickly absorbed and takes a long time before it is eliminated from the body will need to be made in such a way that the bio-active component is in low tires enough to eliminate the pathogen. This also applies to drugs that are toxic to the body cells. The dosage needs to be administered in such a way that the drug is only capable of eliminating the pathogen within the shortest period possible and should have properties that make its elimination faster as well. The manufacturer, therefore, needs to control the way he makes the drug which will in turn inform the dosage.
Lastly, the need for sterility will automatically call for a clean room for drug manufacture. A clean room enables the sterility of the various equipment used in drug development. The equipment and apparatus used in the clean room should not at any time leave the room. All the personal protective equipment worn must be maintained within the clean room too. In addition, the people entering and leaving the clean room must be regulated in such a way that only authorized personnel gets the chance to enter the room.
The controlled area in pharmaceuticals is thus meant to ensure the drug produced meet the standards of the various regulatory body.