Inspections by the US Food and Drug Administration (FDA) are not new to regulated industries and laboratories, as are compliance, enforcement, and criminal investigations. With the goal of addressing and minimizing significant health risks, an FDA inspection can either make or break a company, making a good and lasting impression or tarnishing its image, costing the company time, money, and business. For pharmaceuticals, laboratories, biotech leaders, and drug companies, proving quality systems is paramount.
Access to FDA guidelines and regulations is only the beginning. To achieve a five-star rating, pharmaceutical industry manufacturers and suppliers need to understand what FDA inspectors are looking for and how to respond to enforcement measures in a timely and effective manner.
In the latest FDA inspection processes, the emphasis is on management responsibility for implementing effective quality systems and for ensuring product quality. In other words, the FDA holds management responsible for weaknesses found during an inspection, be that a review of information submitted in applications or inspection of a facility for conformance to requirements.
Using a “bottom-up” approach, investigators now begin their work with a review of system-wide procedures and policies, delving further into records or raw data as needed to find the source of a problem. Random record sampling is another aspect of FDA inspections, allowing investigators to examine a selection of records determined by statistical tables, which in turn allows more ground to be covered in a timely manner. This does not preclude pre-inspection record review, however, as firms are encouraged to submit documentation prior to the hands-on inquiry in order to save time and enhance efficiencies.
Quality over Quantity
In addition to the tenet of management responsibility, also probed are design controls and production and process controls. This includes Corrective and Preventive Action (CAPA), the measures a company takes to eliminate causes of nonconformity or other identified risks. The FDA investigation links these subsystems together in a dynamic process for establishing the quality of a given industry operation.
The emphasis on systems rather than on product and process mirrors current patient-centered approaches to health care where value-based reimbursement have replaced fee-for-service plans in the medical system and where doctors are required to focus on the quality rather than the quantity of care they deliver.
Spotting Problem Spots
Pharmaceutical professionals should take note of recent research findings published by PwC’s Health Research Institute (HRI), which list the top five deficiencies identified during FDA inspections. These frequently occurring quality problems include:
* Manufacturing procedures not written out or fully followed through
* Failure to investigate discrepancies
* Scientifically unsound laboratory controls
* Absence of written procedures
* Failure to follow written procedures
Prepare and Be Aware