An Overview of FDA Regulations for Maintenance

Overview

The Food and Drug Administration (FDA) is responsible for protecting public health by assuring foods, cosmetics, dietary supplements, and drugs are safe, wholesome, sanitary, and properly labeled. They are also charged with ensuring biological devices and medical devices intended for human use are safe and effective. Other responsibilities of FDA include protecting the public from product radiation, regulating tobacco products, and advancing the public health by helping to speed product innovations. These categories of products can be referred to as FDA-regulated products.

FDA inspects manufacturers or processors of these FDA-regulated products to verify they are compliant with relevant regulations or guidelines. In addition to manufacturing sites, the FDA also inspects facilities that conduct clinical trials, labs that conduct biological studies when the studies are intended for use in applying for FDA approval of a medical product, and imported products at the border. Inspections can be conducted for the purpose of pre-qualification, routine inspection, or “for-cause” to investigate a specific problem reported to the FDA.

The role of maintenance in FDA-regulated facilities

FDA ensures quality of FDA-regulated products by carefully monitoring manufacturing or processing site compliance with its Current Good Manufacturing Practices (CGMP) regulations. Specific CGMPs exist for each product category and they can be found under Code of Federal Regulations Title 21. Some examples of these are listed below:

• CFR 21 Part 110: CGMP in Manufacturing, Packing, or Holding Human Food
• CFR 21 Part 111: CGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
• CFR 21 Part 211: CGMP for Finished Pharmaceuticals

Each of these Parts is further broken down into Subparts under which specific requirements are listed. The main roles of the maintenance department can be found in Subparts that focus on buildings and facilities, and equipment. The following Subparts are those found under the the Parts listed above:

• CFR 21 Part 110 Subpart B and C: Buildings and Facilities and Equipment
• CFR 21 Part 111 Subpart C and D: Physical Plant and Grounds and Equipment and Utensils
• CFR 21 Part 211 Subpart C and D: Buildings and Facilities and Equipment

CGMP serve as guidelines to enable a site to produce clean, safe, properly labeled, and effective products. The actual requirements listed under each of the subparts focuses on facility design, equipment, and procedures that promote cleanliness and organization similar to lean principles. Here are some CGMP guidelines and specific ways that maintenance contributes to compliance:

What to expect during FDA inspections

FDA inspections are typically conducted by reviewing systems which correspond to the Subparts that are applicable to the type of product/facility being audited. In the case of maintenance, Subparts for Buildings and Facilities and Equipment are of the main concern.

An FDA inspection is defined as an audit covering two or more systems, with audit of the Quality System being a hard requirement. Different numbers of systems may be covered depending on the nature of the inspection.

During an inspection, FDA auditors document findings with the intent of verifying that a manufacturing site is operating in a sufficient state of control by reference to CGMP regulations. Any non-compliances are documented accordingly to support necessary corrective action. An example of an observation that maintenance should address is “contaminated equipment” or “poorly maintained facilities.” Documentation with photos is also a common practice.

At the end of each inspection, a formal close out is conducted to review findings and recommendations. Auditors may or may not provide their initial recommendations during a close out meeting. However, organizations can expect a copy of the formal inspection report to be delivered within a few weeks after the inspection. Any negative findings may result in different actions ranging from a simple corrective action report to a warning letter or prosecution.