| If your company is associated with the | | | | prior to the inspection date. One of the best things |
| pharmaceutical industry in any way, whether it be | | | | your company can do to ensure maximum |
| manufacturing, supplying, or research and | | | | preparation, is to hire an outside pharmaceutical |
| development, there's a pretty good chance that your | | | | consulting firm, or life sciences consulting firm, that |
| company will be audited with some kind of FDA | | | | specializes in pre-inspection audits, and can help your |
| inspection down the line. When by chance, your | | | | company to prepare itself the best way you can for |
| company is audited, they will have to pass a series | | | | your pre-approval inspection. |
| of FDA inspection tests, to ensure that your | | | | Companies should always be aware that preparing |
| company is running in compliance to FDA standards, | | | | for your pre-approval inspection is not a last minute |
| and that all your research and manufacturing | | | | activity, and takes months of comprehensive training |
| information can be verified. But you may be asking | | | | to be adequately prepared. It is also advisable to |
| yourselves, what are the reasons for pre-approval | | | | organize comprehensive training programs for all |
| inspections anyways, and what can my company do | | | | personnel that will be in any way associated with the |
| to get through it, and pass it the first time around? | | | | inspection. It is not unheard of that personnel |
| The purpose of a Pre-Approval Inspection is for the | | | | behaving in an inappropriate manner, or providing |
| federal government to ensure that all manufacturing | | | | misleading information to inspectors, can cause |
| facilities, as well as development facilities, meet all | | | | inspectors to ask further, more difficult questions, as |
| current GMP codes of conduct and stipulations. Their | | | | well as cause them to look into areas they may have |
| main purpose is to verify that your company's | | | | overlooked. |
| procedural activities are in line with their own | | | | This is why any personnel staff that could potentially |
| commitments to ensure the authenticity and | | | | come in contact with an inspector, should be |
| accuracy of any data contained in your company's | | | | thoroughly trained and briefed well ahead of time, to |
| submitted application file. It is the inspector's job to | | | | avoid any possible problems. Your personnel should |
| thoroughly inspect your facility, as well as any | | | | be instructed on how to conduct themselves around |
| records or data you have available, to make sure | | | | inspectors appropriately, as well as how to |
| that your site produces reliable data information, and | | | | appropriately answer questions. Phrases like "I guess", |
| that all key GMP systems are up to code with | | | | "normally", "usually", "I think", and "most of the time", |
| current GMP standards. | | | | should all be carefully avoided. Because of the wide |
| Thorough preparation work is absolutely paramount | | | | range of do's and don'ts associated with |
| when ensuring that your company is successful in | | | | pre-inspection protocol, preparing your entire staff |
| getting through its pre-inspection test. For your | | | | well ahead of time will be your best chance to safely |
| company to prepare itself sufficiently, many | | | | make it through the pre-inspection process |
| pharmaceutical experts recommend that your | | | | unscathed. |
| company start preparing itself at least 12 months | | | | |