Post-Market Compliance Audits

"We (FDA) are intentionally going to direct investigators to do more inspections near term to your approval for certain kinds of products. So, we have added inspection resources in a program that we have had around for many year, but let lapse for about 10 years, but we have reinstituted this fiscal year and will continue for the next several years at least. This is what we call our post-marketing compliance program. It is designed to get investigators into facilities to look at processes and products that received approval within the last year or so."

" They will primarily look at three things:

  • Process Validation: How you execute it. What does the short-term commercial production experiences tell you about the adequacy of that process and product?
  • Stability: real time, controlled room temperature or whatever its storage condition is, and
  • How you control components: because that is another key variable, and increasingly of greater interest to us."

CDER official Brian Hasselbalch as reported by Bill Paulson. International Pharmaceutical Quality. July/August 2009. Vol. 3, No. 4, pg. 11

BioTechLogic is an industry expert in Process Validation. Our experienced process and quality personnel will review your Process Validation Life Cycle program and executed studies to determine your readiness for an inspection. Examples of our continuous process monitoring audit services include:

  • Review Process Validation Life Cycle Procedures to ensure that they reflects the life cycle approach: Design, Confirm, Monitor, Assess and Change Control (Maintenance and Optimization)
  • Evaluate Design and Development Studies executed to define the manufacturing process
  • Evaluate Process FMEAs that established potential critical unit operations, process parameters, raw materials, components, equipment and facilities
  • Evaluate Lab Pre-Qualification and DOE studies that evaluated potential critical unit operations, parameters and ranges, raw materials, components, equipment and facilities
  • Review executed Process Qualification Report including strategy for increased sampling and statistical rigor
  • Review Life Cycle Trending Procedures or Continuous Monitoring Protocols for process maintenance and improvement