Another category of inquiries to anticipate relates to quality assurance and compliance issues. What, for example, constitutes good laboratory practice (GLP) or good manufacturing practice (GMP) regarding record keeping, employee training, machinery maintenance, or packaging/shipping? What types of internal auditing mechanisms are acceptable and what do external auditors look for during inspections by regulatory agency personnel? Although the starting point in answering such questions is retrieval of pertinent portions of government regulations, other publications often provide far more detail regarding official expectations.
Was this article helpful?