| Having a mock PAI audit for your bio-pharmaceutical | | | | procedures are being strictly followed. They will do |
| company can be a very important process if you are | | | | this by determining whether all production activities |
| looking to achieve the highest quality. The mock audit | | | | and systems comply with all FDA regulations, not to |
| will ensure that the process, system, material, | | | | mention any other regulatory agencies or site |
| method, product, equipment, and personnel, all meet | | | | requirements. They will also identify the depth of the |
| the intended purposes and function, allowing for a | | | | identified problem areas, as well as what steps can |
| reliable and safe production. However, having mock | | | | be done to fix these areas. The mock auditor will |
| audits done by your own company can sometimes | | | | also provide management with the necessary |
| be a conflict of interest, as usually an outside firm | | | | information regarding levels of compliance for the site |
| would be more objective and thorough. When | | | | and its suppliers. |
| preparing for your PAI audit it is an excellent idea to | | | | Having a PAI mock audit may not always be the |
| hire an outside pharmaceutical consultant company to | | | | most exciting idea, but the long term benefits of |
| assist with your mock auditing efforts. | | | | having one of these audits are without question. By |
| The auditor's job in a mock PAI audit is pretty | | | | identifying problems early in the production process, |
| straightforward. Their job is to verify if the | | | | you can not only save your business money, but also |
| company's policies and procedures are being followed, | | | | time and resources as well. It will also bolster your |
| assess the site's GMP practices, verify that the | | | | image to the FDA, and you will know you are ready |
| required systems and controls are in place, and that | | | | for any surprise inspection in the future. It will |
| the factory is meeting all FDA regulations. Also, during | | | | improve your image to your customer base, and you |
| the audit process physical and chemical performance | | | | will receive far fewer product complaints in the |
| characteristics should be clearly identified and | | | | future. By ensuring that your company is running at |
| translated into the correct specifications, including | | | | maximum efficiency, and maximum safety, you are |
| acceptable ranges, etc. The validity of these | | | | ensuring that your business will have what it takes to |
| specifications is verified through the proper testing | | | | be successful in the long haul. |
| and challenge during the development and initial | | | | If you enjoyed this article about a pharmaceutical |
| production. | | | | consultant, please feel free to post it to your site or |
| Some of the auditor's more specific functions may be | | | | blog and forward this link to your friends. Have a |
| more complex. They will investigate the area | | | | great day! |
| thoroughly to verify if company policies and | | | | Don't forget to visit our blog. |