The Importance of an FDA Audit Checklist for Pharmaceutical Establishments

Checklists designed specifically to prepare for FDA inspection are essential tools in any pharmaceutical establishment, helping ensure all necessary steps have been taken prior to an audit by the agency.

Utilizing a low-code platform, it is simple and quick to create a comprehensive checklist that meets FDA regulations. Here are a few helpful hints for getting you underway.

Identifying Violations
Have a thorough checklist at their fingertips can assist pharmaceutical operations managers in preparing for FDA inspections, with this list helping managers assess compliance with regulations and highlight any areas for improvement, which may include facilities, equipment, raw materials, staffing needs or record keeping practices. Furthermore, training Subject Matter Experts (SMEs) on their presentation in front of inspectors is key – their demeanor, attitude and adaptability under pressure will have a huge effect on how effectively they answer inspector questions; simulating investigator interviews can be one way of doing this.

At the conclusion of an inspection, an FDA inspector may issue a Form 483. It’s essential that companies respond within the timeframe specified by this form, clearly showing how their actions address any violations identified by inspectors. Otherwise, warning letters could be issued.

Identifying Corrective Actions
If the FDA inspector will be visiting your site, there are a few things you need to do. First, ensure all key documents and records are organized; this will make finding what the inspector needs easier during an inspection. Also appoint a team of people to accompany and support him or her during this inspection period – this should include an escorting team consisting of primary contact person(s), scribe and runners.

The FDA conducts unannounced inspections of business establishments to ensure they meet FDA safety and efficacy standards in areas like facilities and equipment, product handling practices, employee practices, documentation requirements, etc.

Business establishments that have had multiple serious violations will usually receive a comprehensive inspection, while those with clean records and no recent infractions might get an abbreviated one. An FDA inspector will typically give management an “Inspection Observations Form 483, listing any conditions or practices which they found objectionable during their visit.

Identifying Training Needs
As soon as word spreads that an FDA investigator is in your building, either panic sets in or, for those who have implemented thorough inspection procedures, it should bring excitement. Either way, now is a perfect opportunity to put all that preparation to good use!

Designate a workspace, commonly known as the war room, as the center of activity during an inspection. A team should be on standby to accompany any inspector(s) throughout the site and provide any documentation requested. A designated scribe should take notes in an inspection notebook while “runners” should be ready to respond quickly when necessary.

Be sure to have all of your regulatory documents ready for review, including logs, disclosure forms, FDA Form 1572 and participant profiles. Also prepare pharmacy-related documents like licenses and certificates of analysis before reviewing lab-related documents to ensure they are complete and accurate.

Identifying Documentation Needs
If your company manufactures pharmaceutical products, then compliance with FDA inspection checklist is an integral step towards assuring that they are safe and of top-quality for public health use.

Your quality system must be well documented, from batch records, SOPs, quality control results and recall records to corrective actions or recalls. Furthermore, an appropriate system should exist for tracking complaints against the FDA.

Finally, when facing an inspection you should ensure all relevant documents are available. Ideally these should be easily accessible via an inspection-ready binder and be prepared to respond immediately if any observations from an inspector arise – this will help maintain positive relations with the FDA while saving both time and money while possibly even helping you avoid citations!