By Nigel Smart
After the inspection is finished, you will probably find yourself with a lot of things to be corrected, either in the process, system, documents, or in relation to your cGMP compliance program.. Don't let panic get hold of you, this is normal, and you can still implement some remedial actions to overcome this situation.
It is important to note, however, that perfection is not probably possible at the preapproval stage, as there are too many variables to be considered. As your pharmaceutical consultant may have warned you, most of the issues sometimes deal with the way of presenting facts, figures, and documentation, rather than the real content of the data itself. Some consulting firms in the pharmaceutical business have specialized in inspections, and here are some remedial tips for your FDA preapproval inspection results:
1. MAKE A FORMAL RESPONSE TO ALL 483 ITEMS: 10 to 15 days after the inspection, send a formal response to the FDA district. Though not legally required, this action will clearly show your company's good intentions and may also diminish the possibility for further regulatory action. It will definitely cause a good impression at the FDA.
2. RESPONSES SHOULD REFER TO BOTH PRODUCT AND SYSTEMS: Although you are looking for the approval of a product, the inspection results may have thrown some faulty procedures in data handling or other parts of the whole quality system. You want to show not only that your product is good but also that the system you use can be improved to reach compliance with the highest standards.
3. ATTACH COMPLETE AND AUTHORIZED COPIES OF SOPs: Remember that any discrepancy between presented SOPs and actual behavior (processes) will alert the inspectors. If their observations during the inspection include missing documentation such as Standard Operating Procedures, you'd better write, approve, and implement relevant SOP and attach them to your first response.
4. ACCOMPANY ALL OBSERVATIONS WITH A PLAN OF ACTION: After the inspection, changes will be expected from you and your company. An excellent way to show the FDA that you are on the right track is to accompany each response to 483 items with a clearly defined, reliable, and scientifically justifiable plan. The timelines for implementation need to be clear and realistic and the language to be used should be very specific. Avoid using general statements, as they will sound too vague and untrue.
5. INFORM THE FDA IF YOU MISS THE DEADLINE FOR IMPLEMENTING CORRECTIVE MEASURES: If the corrective measures are taking too long in the implementation, you should inform the FDA and explain what has happened. Tell them also what your new timeframe is.
6. HAVE 483 RESPONSES FILED TOGETHER WITH 483 REPORT: You can request that the responses and 483 report be filed together. It is easier to keep track of all items and corrective measures, and this clearly shows that you are making big efforts to comply with regulations.
Remember that the 483 report and EIR will be available under freedom of information legislation, so it is vital for you and your company to have a copy of the FDA establishment inspection report. That way you can read all of the inspector's additional comments and concerns, and you can use this material for further inspection preparations. Don't let the inspector's findings bring you down. Take their comments as motivational tools to improve your data handling, careful SOP implementation, and preparation for regular inspections. The highest standards need more than one step to be achieved. You are just taking the first steps to get there.
Nigel Smart is a pharmaceutical consultant with extensive experience in the biotechnology and pharmaceutical industry. With Denise Smart, he manages Smart Consulting Group. Visit their blog at www.smartconsultinggroup.com/blog
Source:www.isnare.com |
