The consent decree services in the pharmaceutical industry is quite a bold step which is taken by the company to ensure the welfare of all the different people involved with its functioning and also with the people for whom the company actually makes all the revenues. This is a do good to all procedure and eliminates the possibility of either party involved in the argument from suffering any kind of damage or loss. Other than the pharmaceutical industry this decree finds in application in many other fields of work as well.
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.
Actions taken: The process to comply with cGMP requirements is a doubt that has to be dealt with really carefully by all the manufacturers of different medicinal drugs. The main body of FDA, for whom this CGMP serves as a yardstick for checking the quality of the products going to the consumers, especially medical drugs has the right to issue a written complaint against the accused company, if found guilty and send this company a warning letter.
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 other features that must be taken into consideration include creating an operating manual that comprise of conduct as well as performance, actions acceptable throughout the inspection, certification of inspection results, roles along with responsibilities, and document recovery procedure. The manual must be circulated well in advance to those concerned in the inspection to make clear any contradiction and suitable modification preceding the inspection.
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.
Actions taken: The process to comply with cGMP requirements is a doubt that has to be dealt with really carefully by all the manufacturers of different medicinal drugs. The main body of FDA, for whom this CGMP serves as a yardstick for checking the quality of the products going to the consumers, especially medical drugs has the right to issue a written complaint against the accused company, if found guilty and send this company a warning letter.
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 other features that must be taken into consideration include creating an operating manual that comprise of conduct as well as performance, actions acceptable throughout the inspection, certification of inspection results, roles along with responsibilities, and document recovery procedure. The manual must be circulated well in advance to those concerned in the inspection to make clear any contradiction and suitable modification preceding the inspection.
About the Author:
It was a pleasure working with PharmEng. They were very professional and able to grasp our Program and what we wanted to accomplish. They brought some great ideas and how to achieve it to meet the goals and complete the project effectively How to prepare for an FDA or Health Canada inspection.
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