“ V I RT U A L T O O L B O X ” CASE STUDY Complya’s “Virtual Toolbox” Provides A to Z Support for a Virtual Drug Development Company Development of FDA-compliant and sustainable quality systems for virtual and semi-virtual biotechnology and pharmaceutical companies is a critical component of a company’s growth. In their May 2013 Draft Guidance on Contract Manufacturing Arrangements for Drugs: Quality Agreements, FDA clarified their expectations for virtual companies regarding responsibility for GMP compliance and oversight of contract manufacturing and testing facilities. This Guidance turned a spotlight on this important issue and led to development of our “Virtual Toolbox” for our virtual and semi-virtual clients. Complya’s QA Services SOP Generation ................................. Strategy Complya’s Virtual Toolbox is an integral part of our range of QA services Batch Review & Desposition ................................. Execution Complya Virtual Toolbox Ongoing Support Supplier Qualification & Site Auditing ................................. Quality Agreements ................................. Personnel Training Program ................................. Document Control System Background In a typical case, an early-phase virtual drug development company asked Complya to help meet FDA’s current expectations. The client pointed to a blank wall to illustrate their current level of compliance: • They had no independent Quality Assurance (QA) function within their organization. • They had no existing quality policy, SOPs or systems. • Their employees had never received GMP training. • They had never audited their contract manufacturing organizations (CMOs) or contract testing laboratories. •T hey did not perform any review of batch records, deviations, or test/release data provided by their CMOs prior to distribution of product to the clinic. • They had not established any quality agreements with their key contract facilities. Continued.... complya.com 617.475.3470 Approach Within three months, Complya established and trained the client on several key procedures including: • Establishment of an Independent Quality Unit • Controlled Documentation System • Personnel Training Program • Supplier Qualification and Auditing Program • Batch Disposition • Deviations, Investigations and Corrective/Preventive Action (CAPA) Controls To create and implement these procedures, Complya went to their Virtual Toolbox that contained SOP templates and training techniques as well as background on regulatory filing structure, and used them to streamline the process to save this client significant time and cost. Results Within six months, Complya had implemented several additional GxP controls, including: • Auditing key suppliers for compliance • Creating an effective controlled documentation filing system (on-line and paper-based) • Establishing personnel training files • Writing SOPs for GCP Compliance • Providing a GMP Training Program • Performing Batch Record review and approving deviations from CMOs • Oversight of ongoing GMP, GLP and GCP compliance On an ongoing basis, Complya continued to run the client’s Quality Program in a cost-effecting manner by providing a part-time Senior Consultant and a part-time Document Control Specialist contractor. As multiple programs subsequently entered clinical development, Complya helped to screen, interview, and train new QA employees for this client. Today, Complya continues to support this client with annual internal and supplier audits, periodic batch record review during busy seasons, and ad hoc Quality and Regulatory support across several other areas. complya.com 617.475.3470