Pre-approval inspection plays the most critical role in getting the commercial license for the new manufacturing platform or a new drug. In any instance, if you do not meet these standards during the NDA pre-approval inspection process, it will create lots of legal complexities and unexpected delay in the marketing of your products which cost you more money.
When it comes to FDA, it approves an NDA (New Drug Application) only if all procedures, methods, and facilities used at each step from the raw materials to drugs distribution are enough for preserving the quality, strength, identity, and purity of the drug. It is always helpful to know that are required for cleaning this pre-approval inspection. The PAI (pre-approval inspection) manager is a liaison between the parties. The manager actually reviews your GMP history and observation forms before scheduling your pre-approval inspections.
Major requirements
You are required to fully comply with the CGMPs. Also, you can ensure that quality management professionals confirm all the procedures are satisfied. It is equally important to have every establishment mentioned in this application is inspected regardless of its location. In addition, you can try to list out every associated facility like packagers and contract labs on your application. If you fail to do these tasks, it will lead to FDA 483. As an owner of a pharmaceutical company, you must verify the approval to all commitments mentioned on your NDA application. The generic drugs not on the application and confirm bioequivalence to (NDA) for that it is actually compared. All ANDA applicants need to replicate broad clinical trials which are used in original NDA. Also, you can utilize the bioequivalence research for showing the exact rate at exactly which body absorbs this drug and safety as well as efficacy is equivalent.
What does the FDA expect from applicants?
You should have clinical and pre-clinical data readily available for the review. You must present the data in an authentic and accurate manner. FDA will look for different kinds of details to review that include SOPs, product development report, batch records, and laboratory records. Along with this, FDA inspector requests to view the laboratory product testing and evaluations of analytical methodology. The FDA inspectors also look for some other items for the reviewing process. It includes FDA correspondence, equipment qualification, and change control. Once the FDA inspector reviews all the records, he will announce you the results of nda inspection. In any instance, if you are unlucky to get the FDA 483 form, every item which is addressed before the approval of a drug is listed. All the FDA 483 observations will range from the lack of authenticated methods to lack of storage/data access procedures.
Finally, the inspector recommends the drug approval or for withholding it. Many reasons are available for the withholding of drug approvals. You can try to create a better relationship with the regulatory consulting network for preparing the company for the pre-approval inspection. If you are following the procedures properly, you are able to avoid unwanted delay and other hassles at the pre-approval inspection process.
