FDA 21 CFR Part 312-Requirements | Inspection | Audit Checklist

Article Context:

1. FDA 21 CFR Part 312
2. FDA 21 CFR Part 312 Requirements
3. FDA 21 CFR Part 312 Inspection & Audit Checklist

The Food and Drug Administration (FDA) established a collection of rules and specifications known as 21 CFR 312. It describes the steps that clinical studies must take to obtain FDA approval. These rules must be adhered to guarantee the participants' safety and benefit from the clinical research. The standards for Investigational New Drug Application (INDs) are outlined in federal regulation 21 CFR part 312 from the Code of Federal Regulations. The requirements and procedures governing the use of INDs for the submission to, and review by the FDA of investigational new drug applications offers direction to drug producers and sponsors. (Source: FDA).

Requirements

You must know the FDA 21 CFR Part 312 requirements to get your medicines approved. Five steps must be completed by a pharmaceutical business before the FDA approve the sale of a new prescription drug which are discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring. The company then submits a new drug application (NDA) to the FDA, which must contain the following information:

• The results of the drug test
• Manufacturing data to show the business can produce the medicine appropriately
• Data obtained during the human clinical trials and animal studies
• The drug's proposed label from the manufacturer, which details potential hazards, purposes for which it has been proven to be effective, and instructions for usage

The instructions and drug research for using the drug are reviewed by FDA scientists and doctors. It is then approved and marketed in the US if the results demonstrate that its benefits outweigh its dangers, and the drug can be produced in a manner that finally results in a quality product. Following approval, the FDA will continue to monitor the medicine.

Before making a choice, the FDA does not test the medication. Yet, as part of the approval procedure, the government inspects the factories where the medicine is made. Manufacturers of generic medications also need FDA permission, although they are exempt from having to re-do the brand-name medication's clinical trials. The form used for generic medications is Abbreviated New Drug Application (ANDA). Because medication makers are not required to disclose animal and human evidence to show safety and efficacy, it is labelled "abbreviated."

Inspection

The basic FDA 21 CFR Part 312 inspection rules are discussed below:

According to 21 CFR 312 investigator responsibilities, generic drug companies are permitted to develop medications to receive FDA approval before the brand-name businesses' patents expire. The patent holder must be notified when a generic drug manufacturer applies to the FDA if the patent is being challenged, that is if the generic drug maker contends the brand patent is invalid or the generic drug does not infringe on it.

Medicine should be approved within 10 months of the usual review process. A medicine that provides little to no improvement over already available therapy is subjected to this kind of examination.

Drugs with significant therapeutic advancements or those that fill a medical need where none previously existed are given priority review status. The FDA wants to complete the entire procedure for medicine in six months.

Additionally, the FDA has an expedited approval process for selected medications used to treat serious illness, life-threatening conditions for which there is no effective treatment. The fast approval method has the drawback of allowing an NDA to be granted before the availability of tools to thoroughly assess the drug's efficacy, which is a step that would typically be necessary.

Applications for novel drugs and biological products, as well as resubmissions of initial applications and updates to approved applications, are subject to the PDUFA's (Prescription Drug User Free Act) time constraints.

Audit Checklist

Here are the circumstances of FDA 21 CFR Part 312 audit checklist for medicine approval. FDA conducts both un-announced and announced inspections/audits of clinical investigators in the following situations usually:

• Confirm the accuracy and reliability of data that has been submitted to the agency
• As a result of a complaint to the agency regarding the conduct of the study at a specific investigational site
• In response to sponsor concerns
• Upon termination of the clinical site
• Ongoing clinical trials for providing real-time assessment

Final Verdict

Further information on crucial documentation that must be included in any application to the FDA asking for approval of an IND can be found in FDA 21 CFR 312. This includes a report summarising preclinical studies completed, such as toxicity testing, as well as all reports created by investigators involved in conducting the clinical trial.

The investigator's brochure contains information regarding safety data gathered during previous studies conducted using comparable compounds or agents. The legislation also specifies guidelines for tracking ongoing clinical trials and disclosing any unfavourable outcomes or grave surprises that emerge during a trial.