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 the following inspections:

  Unannounced inspections: These are routine monitoring inspections, typically performed once every two years and encompassing the full-facility and associated records.

  Directed inspections: Also routine, 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.

  Read the regulations: Think you can simply tell the Agency to come back another day to perform their inspection?  Think again. 

  Consider the FDA’s regulation on facility inspections: Subpart A – General Provisions, 21 CFR Part 58.15, Inspection of a testing facility

(b) The Food and Drug Administration will not consider a nonclinical laboratory study in support of an application for a research or marketing permit if the testing facility refuses to permit inspection.  The determination that a nonclinical laboratory study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to the FDA.

The US EPA performs similar types or inspections, though advanced-notice is usually given to the facility and/or principal investigator prior to their arrival.

Gap Analysis: Gap analysis is a technique for determining the steps to be taken in moving from a current state to a desired state.  Characteristic factors of the present situation (“what is”) are cross referenced with the factors required to achieve the future objectives (“what should be”) and the gaps that exist and need to be filled are then identified.

Compliance Assessments: Compliance assessments target new or existing facilities that are migrating from non-GLP 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 the appropriate GLP regulations and provide recommendations on achieving compliance.

  Third Party Inspections: Routine full-facility inspections of contract research organizations (CRO) 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 CRO 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, Freedom of Information Act (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’s when.