Having a mock PAI audit for your bio-pharmaceutical company can be a very important process if you are looking to achieve the highest quality.  The mock audit will ensure that the process, system, material, method, product, equipment, and personnel, all meet the intended purposes and function, allowing for a reliable and safe production.  However, having mock audits done by your own company can sometimes be a conflict of interest, as usual, an outside firm would be more objective and thorough.  When preparing for your PAI audit it is an excellent idea to hire an outside pharmaceutical consultant company to assist with your mock auditing efforts.

The auditor’s job in a mock PAI audit is pretty straightforward.  Their job is to verify if the company’s policies and procedures are being followed, assess the site’s GMP practices, verify that the required systems and controls are in place and that the factory is meeting all FDA regulations.  Also, during the audit process physical and chemical performance characteristics should be clearly identified and translated into the correct specifications, including acceptable ranges, etc.  The validity of these specifications is verified through the proper testing and challenge during the development and initial production.

Some of the auditor’s more specific functions may be more complex.  They will investigate the area thoroughly to verify if company policies and procedures are being strictly followed.  They will do this by determining whether all production activities and systems comply with all FDA regulations, not to mention any other regulatory agencies or site requirements.  They will also identify the depth of the identified problem areas, as well as what steps can be done to fix these areas.  The mock auditor will also provide management with the necessary information regarding levels of compliance for the site and its suppliers.

Having a PAI mock audit may not always be the most exciting idea, but the long-term benefits of having one of these audits are without question.  By identifying problems early in the production process, you can not only save your business money but also time and resources as well.  It will also bolster your image to the FDA, and you will know you are ready for any surprise inspection in the future.  It will improve your image to your customer base, and you will receive far fewer product complaints in the future.  By ensuring that your company is running at maximum efficiency, and maximum safety, you are ensuring that your business will have what it takes to be successful in the long haul.

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