For pharmaceutical companies, quality control is a top priority, and with organizations like CDER1 (Center for Drug Evaluation and Research) "dropping by" for inspections, the quality control process can also be stressful. You might wonder for instance why some CDER inspections are announced and some conducted by surprise. This article, based on an interview conducted for MasterControl, will offer information that gives pharma companies the information that they need to understand the "surprise or no surprise" question.

Quality Control Inspections: Will they be a surprise?
CDER conducts quality control inspections that are either pre-arranged with a pharma company or a surprise altogether. Obviously, the surprise inspections are dreaded by some pharma companies, but consolingly even the CDER's surprise inspections are generally predictable. For instance, a pharma company can count on pre-arranged quality control inspections occurring before the manufacturing process of a drug has taken place and after an application for a new drug has been submitted. At this point of the process, the CDER usually wants to affirm the validity of an application and the feasibility of a safe manufacturing process.

Surprise quality control inspections will usually take place during the manufacturing process of a new drug and are likely to be focused on current Good Manufacturing Process (cGMP) standards.

According to Kristen Evans, a senior regulatory operations officer at the CDER's Office of Compliance, "The goal is to get a realistic look at the firm's day-to-day operations -- to assess the company's ongoing compliance with the good manufacturing practice regulations. Based on a risk-based management approach, companies are "ranked" or categorized according to the degree of [public safety] risks that their products and processes pose. There is a weighted factor or a number that corresponds to a company's risks. Those that fall under the "high risk" category will generally get inspected first. The whole point is for the FDA to match the level of its inspection efforts to the magnitude of a risk."

The important thing to remember is that if a pharma company is aware of the current GMP standards and knows how to manage them effectively along with additional quality control processes (i.e. quality document creation, document approval, change control, CAPA processes, etc.) that effect the daily operations of the company, they will be more than likely to keep the CDER in good humor. Evans provides direction for better daily quality control processes when she states the following in regards to the reasons that a pharma company is likely to receive a disquieting Form FDA-483:

"About four years ago, we implemented a system that allows us to easily track and trend 483s. For fiscal year 2005, the top reason cited on drug 483s was violation of 21 CFR Part 211.22 (d) -- the regulation pertaining to quality control unit. Historically, this problem has been number two. But this year, it became number one. And it might be because we're putting more emphasis on this regulation -- the need for firms to adopt modern quality system concepts."

In other words, in order to take the stress out of surprise quality control inspections and especially to avoid the receipt of 483s, it is becoming more and more essential that pharma companies find the software system that will manage their own quality control processes.

About the Author

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to quality control technology and services, please feel free to contact a MasterControl representative.