SOPs are a critical part of a Company’s drug development infrastructure. They are also the first thing that Inspectors want to see when they are conducting a site audit. Good SOPs create a good perception of an organization. They tell an inspector that the organization is compliant and takes seriously its responsibility for patient safety and data integrity.
Establishing and following Standard Operating Procedures (SOPs) is an absolute must not just for Inspection Readiness but for drug development irrespective of phase of development. In fact, procedures not in writing and not fully followed consistently ranks as one of the top GCP and GMP deficiencies cited by Agencies when conducting regulatory inspections.
The importance of good SOPs cannot be understated. They not only form the backbone of a company’s Quality Management System, they also provide the necessary guidance to companies to ensure they conduct GxP activities in a consistent efficient way. In the fast paced Start-Up environment, consistency is critical. Well written SOPs provide critical guidance on how to conduct clinical trial (or manufacturing) activities which when implemented consistently can reduce errors, churn and the need for rework.
DArcy has written SOPs for Clinical, Manufacturing, Regulatory and Pharmacovigilance organizations.