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Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask by David Nettleton, Janet Gough

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CHAPTER 12

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MAINTAINING INSPECTION READINESS

INTRODUCTION

Who will come to inspect? Young companies know that it is unlikely that the FDA or another regulator will come to inspect. Established companies know that they will, typically every two years or before a new product approval. But inspections are not always by regulators. Companies doing contractual research or manufacturing can be certain that inspections are forthcoming. And companies under consideration for purchase or partnering can expect to see inspectors at the door. During any inspection, for whatever purpose, quality plays a key role, and this means that documentation systems will be subject to scrutiny. This chapter addresses how companies can maintain inspection readiness, and it answers the following questions.

  1. What is the difference between and inspection, audit, and evaluation?
  2. If we pride ourselves on being compliant, do we need to prepare for an inspection?
  3. What should companies do to remain inspection ready?
  4. What does “due diligence” mean?
  5. How can we best prepare for an inspection?
  6. We maintain inspection readiness by conducting regular self-audits, but should we keep the audit reports?
  7. If we do retain our audit reports, do we have to make them available to inspectors?
  8. What's the difference between corrective action and preventive action, and what records do we need to keep?
  9. How does a company know when it ...

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