System and Facility Audit for CROs

Conduct of Phase-I/BA/BE clinical study is a strategic alliance between a contract research organization

Conduct of Phase-I/BA/BE clinical study is a strategic alliance between a contract research organization (CRO) and a pharmaceutical company. Pharmaceutical companies face lot of issues from selecting inefficient CROs leading to inevitable repercussions. Selecting such CROs gives uncertainty in approval of the product by regulatory authorities which ultimately leads to devastating business in the pharma market. To gain competitive advantage in drug discovery and clinical research, selecting suitable CRO has become more challenging for most of the pharmaceutical and biotech companies.

ABC Biologics assists in selecting the CRO and qualifying them by conducting System and Facility audits with well experienced professionals from regulatory environment. Our Inspectors evaluate and qualify the site for quality compliance, adherence to the procedures, sponsor obligations and breach of regulations. Under qualification audit we cover all the divisions of organisation for approval and authorization of Clinical and Bioanalytical project management.

Qualification audits include :

  • Management and Operations strategy
  • Regulatory approvals and refusals
  • Clinical facility
  • Bioanalytical laboratory
  • Quality assurance
  • PK and Statistics
  • Quality control
  • Information technology
  • Archival facility
  • Sample storage facility
  • Administration and Maintenance
  • Supply chain management

Qualification audits in other areas include :

  • Vendor qualification (Service providers)
  • Pre inspection audits
  • GCLP mock audits
  • Site specific audits
  • Annual quality assurance audits