Preparing Pharmaceutical Standard Operating Procedures - Buznew.com

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Preparing Pharmaceutical Standard Operating Procedures

By Carl Messenger-Lehmann


The term CGMP stands for current good manufacturing practice regulations, these include a set of rules and regulations that a particular manufacturer of drugs or medicinal drugs to be more precise, has to comply with during the manufacturing of the medicinal drugs.

The CGMP is a kind of yardstick by the use of which the FDA decides whether the quality of a certain medicinal drug is safe for the consumers to use or not. FDA compliance leaders in the pharmaceutical industry for functioning of a drug are the ideal example of the how the work ethic of a particular medicinal drug manufacturing company should be.

The consent decree is often referred to as the antitrust decree or the stipulated judgement. These kinds of decrees are often used by the federal courts of law to ensure that different business empires or industries stick to the regulatory laws in the areas such as the antitrust law or the environment regulation.

Pharmacy application: The pharmaceutical companies which enter into this kind of decree with the FDA usually have a large number of issues regarding the safety protocols or issues in the manufacturing of the products. In many cases over the years, it has been observed that certain companies have kept their work suspended and the work has resumed only after proper demonstrations have been made by the company, showing that they follow all the rules and regulations on course of the manufacturing of their products. In most cases an expert is usually employed by the FDA to ensure that the manufacturing process of the company is in accordance to the different safety norms.

The correct action plans need to be generated, in order to ensure that the companies do not suffer any more losses. Experts are available in the fields that help to create a proper interface between the companies and the FDA.




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