GMP Audit Readiness and Inspection Management

Inspection template for preparing a site for regulatory audits and FDA inspections, covering document readiness, front room and back room logistics, and response coordination.

Document Readiness and Controlled Records

• Master document index available and current
  A controlled index of SOPs, batch records, validation files, training records, deviations, CAPAs, and change controls is available and reflects current document status.
• Requested records retrievable within 5 minutes
  Sample records requested by the inspection team can be located and produced within 5 minutes without uncontrolled searching.
• Batch records complete and signed
  Selected batch records show no missing critical entries, unresolved corrections, or absent required signatures.
• Deviation, CAPA, and change control logs current
  Open and closed deviations, CAPAs, and change controls are current, traceable, and supported by documented closure evidence where applicable.
• Training records available for key personnel
  Training records for operators, supervisors, and designated inspection responders are current and demonstrate role-appropriate qualification.
• Validation and qualification package accessible
  Equipment qualification, process validation, cleaning validation, and method validation summaries are organized and accessible for review.
• Data integrity controls documented
  Procedures and evidence supporting audit trails, access control, record review, and ALCOA+ expectations are available for inspection.

Front Room Setup and Inspector Experience

• Front room clean, orderly, and free of unrelated materials
  The room contains only inspection-related materials, with no personal items, obsolete documents, or unrelated work in view.
• Seating, table space, and power access available
  Adequate seating, table space, and power access are available for inspectors, note takers, and controlled document review.
• Printer, scanner, and secure document handling available
  A functioning printer/scanner or equivalent controlled document handling process is available for rapid response to document requests.
• Visitor access controls in place
  Visitor badges, sign-in procedures, escort rules, and restricted area boundaries are clearly defined and enforced.
• Confidential or proprietary information protected
  Non-requested confidential information is secured or removed from view to prevent accidental disclosure.
• Room signage and directions posted
  Clear signage identifies the inspection room, restrooms, emergency exits, and any restricted access points.
• Emergency egress unobstructed
  Exit routes from the front room are unobstructed and clearly marked in accordance with fire-life-safety expectations.

Back Room Response Coordination

• Back room staffed with assigned roles
  Roles for lead coordinator, document runner, SME support, note taker, and escalation contact are assigned and understood.
• Response log maintained for all inspector requests
  All questions, document requests, and commitments are logged with time, owner, status, and follow-up due date.
• Single point of contact controls outbound responses
  Only the designated lead or approved delegate provides responses to inspectors to prevent inconsistent statements.
• SMEs available within defined response time
  Subject matter experts for quality, manufacturing, engineering, validation, and EHS can be reached within the site response target.
• Escalation path documented and tested
  Escalation contacts for quality leadership, site leadership, legal/regulatory, and corporate support are documented and current.
• Hold statements and response discipline reviewed
  The team has reviewed guidance on pausing to verify facts, avoiding speculation, and committing only to supported follow-up responses.

Facility Walkthrough and Operational Readiness

• Housekeeping and material storage orderly in inspected areas
  Aisles, work surfaces, and storage areas are free of clutter, obsolete materials, and uncontrolled WIP that could create a deficiency.
• Equipment status labels current and accurate
  Equipment is clearly labeled with current status such as in service, under maintenance, cleaned, or quarantined as applicable.
• Calibration and preventive maintenance current
  Critical instruments and production equipment have current calibration or preventive maintenance status with no overdue items in the inspection path.
• PPE requirements posted and available
  Required PPE is posted at entry points and available for visitors and staff entering controlled areas.
• Critical process controls operating within limits
  Visible process parameters relevant to the inspection route are within approved limits and supported by current records.
• Open deficiencies in walkthrough areas triaged
  Known deficiencies in areas likely to be observed have been assessed, assigned, and documented with interim controls where needed.

Inspection Conduct, Communication, and Follow-Up

• Opening briefing completed with assigned team
  The team has reviewed roles, escalation rules, response discipline, and the current inspection agenda before inspector arrival.
• Commitments tracked with owner and due date
  Any promised documents, clarifications, or corrective actions are logged with an owner and target completion date.
• Potential non-conformances escalated promptly
  Observed deficiencies or potential non-conformances are escalated through the site response process without delay.
• Closeout debrief scheduled
  A post-inspection debrief is scheduled to review observations, commitments, and corrective action ownership.
• Inspector signature captured
  If required by site procedure, the inspection record is signed by the inspector or designated site representative.