NeuAge Institute (NAI)

3 Tips for Understanding FDA Audits During Pharmaceutical Quality Control Training

pharmaceutical quality control training
If you’re involved in the development or manufacturing of pharmaceutical products, sooner or later you’ll encounter a visit from the FDA. The U.S. Food and Drug Administration is an organization responsible for verifying the safety and validity of foods, medications, and other products. To do so, it conducts audits—or inspections—of manufacturing facilities. 

For pharmaceutical manufacturers, passing an FDA audit inspection is crucial. That’s why professionals working in these facilities need to know what to expect and prepare well in advance in order to prevent setbacks in the production process. Students in pharmaceutical quality control training will cover the US FDA and global regulatory requirements to prepare them to enter their careers with a solid understanding of the inspection process. To get started, read on for a quick guide to understanding FDA audits. 

Know What the FDA Is Looking for 

In order to pass an FDA audit, you should make an effort to understand the purpose of the audit. FDA audits apply to biotechnology, medical devices, pharmaceuticals and other drug products, and more. The FDA conducts audits for several reasons, including pre-approval inspection, new drug applications, and pre-market approval applications. In each case, the basic goal of an FDA audit is to verify compliance at the relevant production stage. 

What does that mean for a pharmaceutical company? It means being able to demonstrate that all their production activities comply with the regulatory requirements and quality standards laid out in the industry. Most importantly, to demonstrate compliance, companies need the appropriate documentation in place. Students in pharmaceutical quality control training will learn more about what to expect from an FDA audit process by examining case studies of past FDA audits in the pharmaceutical industry. 

pharmaceutical certification
FDA audits are designed to verify compliance at different stages of pharmaceutical production

Preparing for an FDA Audit After Pharmaceutical Quality Control Training

Preparation is crucial to passing an FDA audit. With so many different teams and production processes in place, pharmaceutical companies should ensure that their facilities are ready and all personnel is briefed. Anyone who will come into contact with an FDA agent should know what they may be looking for and what to say. Equally important, companies should have all relevant documentation ready and be prepared to go through it with an FDA agent. 

A good way to ensure that you have all corners covered is to conduct an internal audit before the FDA’s arrival. An internal inspection will give you an idea of the company’s level of compliance and identify any glaring deficiencies. That way, you can develop an action plan to quickly address any problems. 

While training for their pharmaceutical certification, students at the NeuAge Institute will review the expectations of FDA audits and learn the value of implementing their own internal audit process to guarantee compliance. 

pharmaceutical institute
Graduates of a pharmaceutical institute should ensure all facilities, documents, and personnel are prepared for an FDA audit

What to Expect After an FDA Audit 

While thorough preparation should be a company’s main focus, it’s also important to prepare for the aftermath of an FDA audit. Even with a solid plan in place, issues may still arise that the company will have to respond to. At the end of the audit, an FDA agent may discuss any notable findings with the company management and leave them a written report that references specific areas of concern. 

A pharmaceutical company should work with the FDA at this stage to understand any issues and develop corrective measures. By collaborating with the investigator and acting promptly, companies can demonstrate their willingness to correct any problems. In the eyes of the FDA, this can be a sign of a company’s positive management and commitment to compliance. 

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