| This is the drug manufacturer's nightmare: the phone | | | | have, or not have, to say or show the FDA. |
| rings and an FDA official announces an upcoming | | | | 2. Identify and work on weaknesses |
| inspection. Even though they are clearly necessary, | | | | Smart professionals work on identifying the |
| FDA inspections are a weight on pharmaceutical | | | | weaknesses that could attract the FDA's attention |
| companies' shoulders. Without these inspections, | | | | before this happens. Some examples are potential |
| pharma companies cannot keep the FDA's approval | | | | contamination, under maintenance, and unclean areas. |
| to sell their products. | | | | 3. Select key people to accompany the FDA official |
| It is the FDA's duty to call in advance to announce an | | | | Train two or more employees who supervise the |
| inspection, its purpose, duration, and number of | | | | major processes to follow the FDA official. Teach |
| people involved. On inspection day, the FDA official | | | | them how to treat and interact with this person. |
| will ask to see the top management person on site, | | | | |
| and he will show his credentials and an FDA 'Notice of | | | | 4. Write an operations manual |
| Inspection' to that person. Afterwards, a thorough | | | | Operations manuals should be the main reference in |
| inspection of the facilities will begin, while one or more | | | | the facility. Employees must have continuous access |
| key employees tag along. After a few days, the FDA | | | | to them in order to check actions and steps to |
| will send an 'Inspectional Observations form' to the | | | | maintain FDA compliance at all times within their |
| leadership team informing them about any | | | | areas. This provides education and encouragement to |
| unacceptable conditions they have found in regards | | | | go through any inspection with confidence. |
| to products, processes, or other violations to the | | | | |
| FD&C Act. | | | | 5. Make regular FDA compliance checks |
| The results of such an inspection can range from no | | | | Don't wait until the FDA is there to identify the |
| needed actions to a complete closing of the facilities | | | | problem areas, identify them yourself and work with |
| and administrative, civil, or criminal actions against the | | | | your personnel to fix them. This will give your people |
| company. Normally, the FDA will recommend actions | | | | confidence because they know what they are dealing |
| to improve operations in line with the FD&C Act. | | | | with and they know how to solve it. |
| Given the serious nature of this process, it is | | | | FDA inspections are normally not happily welcomed |
| necessary to plan ahead and be ready for the | | | | because they require a lot of additional resources and |
| eventual call. Here are 5 tips to welcome the FDA | | | | energy, however, every pharmaceutical consultant |
| with a smile on your face: | | | | will tell you that being prepared is not only the best |
| 1. Implement regular internal FD&C Act | | | | way to pass the inspection, but also to get your |
| compliance training | | | | business under control and avoid worrying about |
| The best way to ensure a successful FDA inspection | | | | what is out of your hands. |
| is to ensure the facility complies with FDA regulations. | | | | If you liked this article, tell all your friends about it. |
| Every employee must be aware of the products and | | | | They'll thank you for it. If you have a blog or |
| processes' FDA standards for the area he or she | | | | website, you can link to it or even post it to your |
| tends to. Employees have to be trained to stay calm, | | | | own site (don't forget to mention as the original |
| be respectful, and follow the FDA official's requests, | | | | source). |
| as well as to know their rights about what they | | | | |