The U.S. Food and Drug Administration (FDA) is one of the most influential drug regulatory agencies in the world, and its audit types are of great significance to ensure the quality, safety, and efficacy of drugs. This article focuses on the classification of "FDA audit types" into three types of audits: pre-approval inspections (PAIs), periodic inspections, and causal inspections, and their role in drug regulation.
Purpose and significance
Pre-Approval Inspection (PAI) is the FDA's inspection of a new drug application or biologics license application (BLA). Its main purpose is to ensure that the pharmaceutical manufacturing process, facilities, quality control, etc., meet the requirements of Good Manufacturing Practices (GMP). Through the PAI, FDA can assess the ability of drug manufacturers to produce high-quality, safe, and effective medicines.
Audit content
In the PAI process, FDA auditors will conduct inspections based on six major systems, including quality system, production system, material system, packaging and labeling system, plant facilities and equipment system, and laboratory system. Auditors conduct a comprehensive assessment of all aspects of the pharmaceutical manufacturer to ensure that the company has the ability to consistently produce high-quality pharmaceutical products.
Purpose and significance
Periodic inspections are inspections conducted by the FDA on approved drug manufacturers. The main purpose is to ensure that companies continue to comply with GMP and other relevant regulations. Through regular inspections, FDA can monitor whether drug manufacturers are maintaining a stable quality management system over the long term.
Audit content
Regular inspections focus on compliance with GMP requirements in the production process and the effective implementation of the quality management system. Auditors will check the company's production records, inspection reports, employee training records, etc., to ensure that the drug manufacturer continues to produce high-quality drugs.
Purpose and significance
There are inspections that are done in response to a specific problem or complaint. Its main purpose is to investigate whether there are quality problems in the drug manufacturer and whether the company has taken effective measures to solve these problems. Through cause-based inspections, FDA can identify and address potential risks to drug manufacturers in a timely manner.
Audit content
Cause-based inspections usually focus on the production links related to complaints or problems. Auditors will conduct a detailed inspection of the relevant records, equipment, personnel, etc. of the drug manufacturer to determine the root cause of the problem and assess whether the corrective measures taken by the enterprise are effective.
The type of FDA audit is of great significance in drug regulation. Through pre-approval inspections, periodic inspections, and cause-based inspections, FDA can protect public health by ensuring that drug manufacturers adhere to strict quality and safety standards. For China's drug regulatory agencies, learning from the FDA's audit experience, further improving China's drug regulatory system, and improving drug quality are important measures to ensure the safety of drug use by the people.