If you are a manufacturer ready for FDA review, what is the first thing you should do? First of all, you must have a reasonable understanding of how FDA function. It includes processes and mechanisms associated with the FDA review. FDA offers relevant curriculum, manuals and guides for you to understand their requirements and processes. In this article we will discuss the curriculum and the training you need to successfully pass FDA inspection of or withdrawal.
Authentic and updated information
You can always refer to the official website of the FDA, fda.gov for any information you need about the FDA process. For example, you may refer to prescribed procedures manual (RPM) on the official website of the FDA to know more about the internal FDA procedures. For more information about this topic, you can refer to the Compliance Policy Guide (CPG).
If you want to know about the process and requirements of the FDA, you can refer to Investigations Operations Manual (IOM). If you want to know the current status of FDA on any particular subject, you can refer to “Manual”.
How does the FDA review happen?
As a first step toward approval of the product, you need to know how the FDA review happens, what their specific requirements are and how they go through the review process. For beginners, it is important to know the documentation process. When FDA officer visits the site, the first document to be published on the site manager’s form “FDA 482”, a notification to the inspection and it is the first official document from the establishment. You can have a look at this photo in PDF format in the “Downloads” in the official site FDA.
How to prepare for the examination?
When the FDA rules officials start inspection, they follow the manual is known as the IOM (Investigations Operations Manual). For more information about this, follow the sub-section 5.5 for Drugs and Chapter 5 of “establishment inspection”. This chapter gives you detailed information on how to prepare for the examination. It will also highlight the FDA inspectional approach.
To prepare the examination in a better way, you need to understand the goals of the inspection or audit in the first place. Regulatory authorities want to make sure that good manufacturing and hygiene concepts are fully followed by the manufacturer. It is obvious that the authorities want to make sure that the finished product has the required purity, quality and special identity it is connected.
The purpose of the inspection is also to identify practices that could lead to a violation of the law as far as production and distribution of goods are concerned. So, the job of FDA officials is to make sure Official Compendium is fully met. Regulators would also want to make sure that the manufacturer is required FDA approval for the drug is distributed. It may not be counterfeit or imported products on the market.
need for training
To effectively prepare for these inspections, the companies should arrange appropriate training for in-house staff. Even smaller issues such as nervousness, contradictory statements by members, and arguments with the agency representative may raise the level of curiosity and suspicion. If you are a professional or pharmaceutical manufacturer looking for some kind of consistent training for your employees, you should find a coach who is well versed with the Regulatory Affairs and has experience dealing with FDA and get product approval. They will train you on how to prepare for a meeting with the FDA, including best practices and dos and don’ts etc. They will also provide you with important information on interactions with regulators and how and when to go for it.