Support of Existing Quality Assurance Units Case Study

The size of the Registration Quality Assurance (RQA) unit of this pharmaceutical company provides all Quality Assurance requirement for the “steady-state” level of workload.  Occasionally, pivotal clinical studies are completed simultaneously just before submission for an IND or NDA.  Typically, the bioanalytical laboratory is required to analyze thousands of samples within a few weeks.  To assure that the turn-around time required for data and report audits by RQA are not the time-limiting factor for submission to FDA, QAI is called upon to provide contract Quality Assurance support. QAI personnel travel to the bioanalytical (BA) laboratory site, often three or more auditors at a time, to conduct “rolling audits” of the BA data, auditing data packets as they become available from the BA personnel.  The database of results is audited progressively as results become available.  QAI keeps records of all results audited, and of all samples requiring dilutions or repeats for other reasons (such as possible pharmacokinetic outliers).  By the time the last repeat samples are analyzed, all data have been audited and the database is locked in preparation for WinNonLin analysis. In addition to a data and report QA audit report, the product of the audit often includes a Systems Audit report that itemizes observations made to the Quality Assurance program.  Since QAI auditors have become familiar with the pharmaceutical company’s own standard operating procedures (SOPs), they apply their experience to identifying areas of the Quality System that may require improvements. The advantages to the client are multiple:
  • The QAI team is used to working as a team for an efficient audit.
  • The “new eyes” to the Quality System identify possible upgrades.
  • The study is submitted to FDA on time.