How to comply with cGMP requirement

PharmEng Technology

The improvement in the field of technology is taking place by leaps and bounds every day, this rapid rise in the improvement in technology is also making its presence felt in the field of medicine and pharmacy. The quality of drugs being produced have to be monitored regularly to ensure that there is no presence of adulteration in the medicinal drugs.


How to pass for an audit with FDA and Health Canada inspection is a very important aspect of the business for officials of a specific company, and they need to keep this in mind.


Most of the clinical trials of these potent drugs have shown safety of health for the consumers, in order to validate the claim of the manufacturers of the drugs and also to ensure the quality and integrity of all the data which have been provided by the company involved in the manufacture of the drugs.


Procedure to prepare for FDA


The names, positions and other such similar data regarding all the stuffs present in the manufacturing unit of the company should be compiled in a list and be made absolutely ready for the inspector to go through, to be on the safe side, a number of extra copies of this list of documents should also be made. FDA compliance of leaders in the pharmaceutical industry is a part of the business which must be completed and kept aside without any kind of delay.


Providing ample amount of space to the inspector is another very important aspect that is needed to be followed by the people. The person should be kept away as much as possible from all busy areas of the company. Approvals by the IRB, a complete list of all credibility certificates, details regarding all labs that have been used as well as copies of all protocols and conditions that the company has abided by should be present in the audit for the inspector to take a look at. All the different staffs of the company should also be fully prepared for facing an interview at any point of time. This is the correct process by which a company can pass an audit with FDA and Health Canada.


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