Quality Assurance

Quality Assurance at Panexcell is an independent function and ensures ethical conduct of clinical studies as per GCP, GLP and other applicable regulatory requirements.

Involved primarily in:

  • Preparation, review, approval and distribution of standard operating procedures.

  • Induction and training of new joinees in respective technical functions, GCP/GLP, safety measures and ongoing training of the employees in all relevant aspects for enhancing further skills.

  • Periodic internal audits followed up with Management review of systems, processes and suitability of existing procedures Archiving of data.

  • Ensuring compliance as per SOPs, applicable regulatory guidelines and GCP/GLP.

  • Audit of the studies (clinical, bioanalytical, PK and Statistical) during Initiation, In-process, Reporting phase to keep close checks on activities.

  • Providing authentication for Method validation and study reports.

  • Preparation for external audits and Inspections.