If you are a manufacturer getting ready for an FDA inspection, what is the first thing you should do? First of all, you must have a fair understanding of how FDA functions. It includes the processes and systems involved with an FDA inspection. FDA offers relevant study material, guides and manuals for you to understand its requirements and processes. In this article, we will discuss the study material and training you need to successfully pass their FDA inspection or audit.You can always refer to the official website of FDA, fda.gov for any information you need about FDA processes. For example, you may refer to Regulatory Procedures Manual (RPM) on the official website of FDA to know more about internal FDA procedures. For additional information on this subject, you can refer to Compliance Policy Guide (CPG).If you want to know the processes and requirements for FDA, you can refer to Investigations Operations Manual (IOM). If you want to know the current position of FDA on any specific topic, you can refer to “Guidance Documents”.
As a first step towards product approval, you need to know how an FDA audit happens, what their specific requirements are and how they go through the audit process. For beginners, it is important to know the documentation process. When the FDA officer visits the site, the first document to be issued to the site manager is the form “FDA 482”, which is the Notice of Inspection and it is the first official document from the agency. You can have a look at this form in the PDF format in the “Downloads” section of the FDA’s official site.When FDA regulatory officials begin the process of inspection, the manual they follow is known as the IOM (Investigations Operations Manual). For more information on this, follow sub-chapter 5.5 for Drugs and Chapter 5 for “Establishment Inspections”. The chapter gives you complete information about how to prepare for the inspection. It will also throw light on the inspectional approach of FDA.To prepare for the inspection in a better way, you need to understand the objectives of the inspection or audit in the first place. The regulatory authorities want to make sure that the good manufacturing practice and concepts of sanitation are fully adhered to by the manufacturer. It is obvious that the authorities would like to make sure that the finished product has the required purity, quality and specific identity it is associated with.
The purpose of inspection is also to identify the practices that could lead to violation of the Act as far as production and distribution of products are concerned. So, the job of the FDA officials is to make sure that the Official Compendia is fully conformed. The regulators would also want to make sure that the manufacturer has the required FDA approval for the drugs being distributed. There must be no counterfeit or diverted drugs in the market.To effectively prepare for these inspections, the companies should arrange proper training for their in-house staff. Even the smaller issues such as nervousness, contradiction of statements by the team members, and arguments with the agency representatives can raise the curiosity level and suspicion. If you are a pharmaceutical professional or a manufacturer looking for some kind of compliance training for your staff, you should find a trainer, who is well versed with regulatory affairs and has experience dealing with the FDA and getting product approvals. They will train you on how to prepare for meetings with the FDA, including the best practices and dos and don’ts, etc. They will also provide you valuable information about interactions with regulators and how and when to go for that.