Complya Consulting Group Virtual Toolbox Case Study

“ 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 In their May 2013 Draft Guidance on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
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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