Inspections
Regulatory inspections are “business as usual” in a day in the life of contract research organizations…or at least they should be. QAS can make sure regulatory inspections run as smoothly and efficiently as possible.
What to anticipate
The US FDA can perform one or all of three types of inspections:
Unannounced inspections
These are routine monitoring inspections, typically performed once every two years and encompassing the full-facility and associated records.
Directed inspections
These are performed on data and/or reports. They involve the associated facility areas, equipment, records, and personnel pertaining to the study(ies) currently under review by the Agency.
For-cause inspections
These may be prompted by “whistle-blowers” from within any given contract research or sponsor organization, or as a result of undisclosed or unforeseen adverse event reporting in marketed products.
The US EPA performs similar types of inspections, though advanced-notice is usually given to the facility and/or principal investigator prior to their arrival.
Read the regs
Think you can simply tell the Agency to come back another day to perform an inspection?
Think again. Consider FDA’s regulation on facility inspections:
Subpart A--General Provisions, Sec. 58.15 Inspection of a testing facility.
QAS Can Help
Quality Assurance Services can help you prepare for anticipated agency inspections or assist in the maintenance of current internal inspection procedures. We offer:
Compliance Assessments
Compliance assessments target new facilities or existing facilities that are migrating from non-GLP (Good Laboratory Practice) work to a more regulated GLP environment. The compliance assessment will detail the strengths and weaknesses of the facility and its personnel with respect to appropriate GLP regulations and provide recommendations on achieving compliance.
What about the reality of a 483? What you don’t want to get is a warning letter.
Third Party Inspections
Routine full-facility inspections of contract research organizations already performing GLP-regulated studies, for the purpose of current or future study placement.
Subcontractor Inspections
Targeted inspections of subcontractors or vendors that will be utilized by the sponsor or contract research organization for the conduct of GLP studies.
When it comes to inspections, the best defense is a good offense. Be proactive in your approach to regulatory inspections instead of waiting to react. Review FDA Gold Sheets, FOIA-request recent inspection histories, conduct mock inspections, etc. Again, in the GLP arena it’s not a matter of if you will be inspected…it is when.
All inspections will be performed in compliance with the appropriate regulations and your company's standard operating procedures, as applicable.