🎯 Objective

To independently verify that all processes, controls and records in the OSD and External Prep plants are implemented as documented, remain effective, and drive continual improvement.

🗓️ Audit Program & Schedule

FrequencyScopeLead AuditorParticipants
MonthlyHigh-risk processes (e.g. potent API handling, critical equipment)QA SeniorProcess Owners
QuarterlyFull-scope (all departments)QA ManagerQA/QC, Production reps
AnnuallySystem-wide (including support functions: HR, Maintenance)Head of QACross-functional team

📝 Audit Planning

  1. Define Scope & Criteria
    • Map against ISO 9001:2015 clauses (esp. 4–10) and GMP requirements.
    • Reference SOPs, BMRs, cleaning/validation protocols, CAPA records.
  2. Develop Audit Checklist
    • Process-based: e.g. dispensing, granulation, homogenization, filling, packaging.
    • Clause-based: e.g. 7.5 Documented information, 8.5.1 Operational control, 9.2 Internal audit.
  3. Notification & Logistics
    • Issue audit notice 2 weeks in advance.
    • Gather relevant procedures, past audit reports, training records.

🔍 Audit Execution

  1. Opening Meeting
    • Confirm scope, criteria, confidentiality, and logistics.
  2. Process Walk-throughs
    • Observe operations in cleanrooms, labs, packaging lines.
    • Verify environmental conditions, gowning, in-process checks.
  3. Record Reviews
    • Check BMRs, calibration logs, deviation and CAPA files.
    • Ensure ALCOA+ data integrity in analytical reports.
  4. Interviews
    • Talk to operators, supervisors, QC analysts to confirm awareness of QMS roles.
  5. Nonconformity Identification
    • Classify major vs. minor findings with objective evidence.

📊 Reporting & Metrics

DeliverableContentsTarget TAT
Audit ReportScope, findings (with ISO/GMP ref.), positive observations, CORRECTIVE ACTION requests5 working days
Nonconformity LogDescription, root cause, responsibility, due dateImmediate entry
Trend Dashboard# of audits, # findings by category, closure rate, recurring issuesMonthly review

🔄 Follow-Up & Closure

  1. Corrective Action Plans
    • Root-cause analysis (5-Why, Fishbone).
    • Define SMART CAPAs with timelines & owners.
  2. Verification
    • QA verifies implementation and effectiveness (e.g. through mini-audits).
  3. Management Review Input
    • Summarize audit trends, CAPA status, resource needs under Clause 9.3.

🎁 Benefits & Continuous Improvement

  • Proactive Risk Control: Uncover weaknesses before customer/regulator finds them.
  • Data-Driven Decisions: Use audit metrics to prioritize training, equipment upgrades, process changes.
  • Culture of Quality: Regular audits reinforce accountability and awareness among all staff.
  • Regulatory Readiness: Demonstrates robust self-assessment to regulators (FDA, WHO, MHRA).