Support of Existing Quality Assurance Units (QAU)

The size of the Registration Quality Assurance (RQA) unit of this pharmaceutical company provides all quality assurance (QA)requirement for the “steady-state” level of workload. Occasionally, pivotal clinical studies are completed simultaneously just before submission for an investigational new drug (IND) or new drug application (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 the RQA were not the time-limiting factor for submission to the U.S. Food and Drug Administration (FDA), Quality Assurance Consultancy was called upon to provide contract quality assurance (QA) support. Our auditors traveled to the bioanalytical (BA) laboratory site, often three or more of them at a time, to:
  1. Conduct “rolling audits” of the BA data
  2. Audit data packets as they became available from the BA personnel. The database of results was audited progressively as results became available. Records were maintained 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 were analyzed, all data had been audited, and the database was locked in preparation for WinNonLin analysis. In addition to a data and a QA audit report, the audit often included a Systems Audit report that itemized observations made regarding the QA program. Since our auditors had become familiar with the pharmaceutical company’s own standard operating procedures (SOPs), they applied their experience to identifying areas of the quality system that required improvements.


The advantages to the client were multiple:
  • Our experts created an environment that produced an efficient audit
  • The “new eyes” to the quality system identified possible upgrades
  • The study was successfully submitted to the FDA on time