Considerations in GMP Auditing
Covers some of the basic considerations for GMP auditors to review.
Using Checklists in GMP Audits
The checklist is a popular tool for helping cGMP auditors conduct thorough, systematic, and consistent audits. However, it should be used as a tool, not treated as the entirety of the audit, and should not substitute for proper planning and climate-setting before the audit begins.
A well-prepared checklist ensures auditors cover critical cGMP requirements, stay focused on important issues, and ask more objective questions than they might extemporaneously. It also signals to those being audited that the auditor is prepared.
Disadvantages include the following:
- Checklists can become a crutch rather than a tool
- They do not replace proper audit planning
- Their focus may be too narrow to identify all problem areas
- They can be intimidating to those being audited
- Questions may be outdated or require deeper investigation than a simple answer allows
Auditors should be trained to ask open-ended questions — such as "show me how this procedure works" — rather than relying solely on yes/no questions. Walking through a procedure step by step confirms not just that it exists, but that it is current, adequate, and properly followed. Auditors should also ask those being audited, "Do you have areas of concern you'd like me to examine?" Observations and conclusions should be recorded in the space provided or in a notebook, as they will be essential when writing the audit report.
Avoid rating scales. A high but inaccurate score can create a false sense of security, allowing serious deficiencies to go unnoticed until an FDA inspection. Instead, note what meets requirements and clearly identify what does not.
Since quality control represents a cost, there is no advantage in exceeding "adequate" — the standard needed to ensure a product's safety, purity, and efficacy. That said, in quality-committed companies, "adequate" often means considerably more than minimum compliance.
The answer to "should you use a checklist?" is probably yes — but it must be thorough, current, and used by auditors trained in effective questioning techniques.
GMP Audit Checklist For Drug Manufacturers
A 7 page audit checklist, based on 21 CFR Parts 210 and 211, can be customized to use for an internal GMP audit.
FDA Inspection Basics
The U.S. Food and Drug Administration (FDA) protects public health by ensuring that foods and medical products meet high standards for safety, quality, and effectiveness. To do this, the agency uses risk‑based methods to select domestic and foreign facilities for inspection. An FDA inspection is a formal, onsite examination to evaluate a facility’s compliance with federal laws and regulations. While inspections are essential, they provide only a snapshot in time and are part of a broader oversight strategy to continuously monitor FDA‑regulated products.
Products manufactured outside the United States must meet the same requirements as those produced domestically. The FDA actively monitors the global supply chain to address potential risks and maintain public confidence in product safety, regardless of origin.
The FDA inspects a wide range of entities, including manufacturers of drugs and vaccines, blood banks, food processing facilities, dairy and produce farms, animal feed processors, compounding pharmacies, outsourcing facilities, and tobacco manufacturers. Inspections also cover clinical trial sites, research laboratories, foreign facilities, and imported products at U.S. borders.
Overview of FDA Device Regulations
The FDA’s Center for Devices and Radiological Health (CDRH) regulates companies that manufacture, repackage, relabel, or import medical devices sold in the United States, as well as radiation‑emitting electronic products such as lasers, X‑ray systems, ultrasound equipment, microwave ovens, and televisions. Medical devices are classified into Classes I, II, and III based on risk, with regulatory control increasing by class. Most Class I devices are exempt from premarket review, most Class II devices require 510(k) premarket notification, and most Class III devices require premarket approval. Manufacturers must comply with registration, device listing, clinical study requirements, quality system regulations, labeling rules, and medical device reporting requirements.
FDA Guidance Document: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
This guidance helps manufacturers apply modern quality systems and risk management approaches to comply with the FDA’s current good manufacturing practice (CGMP) regulations in 21 CFR parts 210 and 211. It outlines a comprehensive quality systems model aligned with CGMP requirements for manufacturing human and veterinary drugs, including biological products. The guidance explains how implementing these quality systems can support full compliance with existing regulations. It does not introduce new requirements or replace CGMP regulations. Manufacturers are encouraged to consult 21 CFR parts 210 and 211 directly to ensure complete regulatory compliance.
FDA’s Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections
On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began utilizing the inspection process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850). After February 2, 2026, the FDA is no longer using the following documents: Inspection of Medical Device Manufacturers (7382.845) and Medical Device PMA Preapproval and PMA Postmarket Inspections (7383.001).
Effective February 2, 2026, Medical Device Manufacturers should reference: Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850), effective February 2, 2026. This compliance program includes the new inspection process, which aligns with the requirements of the Quality Management System Regulation (QMSR).