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Process Readiness: GMP Mock Inspections

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1. Be Inspection Ready
  • GMP Facilities should be inspection ready every day. First impressions count.
2. Establish Procedures
  • A Regulatory Inspection Procedure and Inspection Manual detailing the conduct of an inspection should be in place.
3. SME Identification
  • It is important to identify the right technical expert for each functional area. Personality and expertise are both important in SME selectin.
4. Know Your Documents
  • The identified SMEs should be familiar with the document they may discuss. Examples include VMP, SMF, Specifications, SOPs, Policies, etc.
5. Facilities and Logistics
  • Hosting facilities, Back Room Operations, seating, computer setup and logins, refreshments all need to be locked down for a successful first impression.
6. Train Your Team
  • Personnel engaged in GMP operations should be trained on the conduct of any inspection.
  • Front Reception plays a key role in establishing a good first impression.
7. Secrets to Success
  • Be well prepared.
  • Provide a good first impression.
  • Well-trained personnel.
  • Well written, clear procedures.
  • Good inspection management.
  • Assurance that SMEs have the required technical knowledge, expertise, confidence, and presentation skills.
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