Copyright © 2010 Quality Compliance Partners, Inc.�
GXP Compliance Manufacturing and Supplier Audits�
include, but are not limited to:�
v� – Good Manufacturing Practices�
v� – Good Laboratory Practices�
v� – Good Clinical Practices�
v� Computerized Systems Audits�
v�
v�
With our expertise in GXP audits,�
can help all parties across the entire product life cycle,�
manage and improve the quality of their products in a globally consistent,�
reliable and efficient manner through services and solutions tailored�
specifically for life science quality assurance.�
The life science industry is faced with increasing regulation and guidance�
on efficacy, quality, and safety during the entire life cycle of their�
products. Quality departments are expected to control compliance of the�
product life cycle, from incoming goods to the delivery of finished�
product.�
� Compliance audits of manufacturers of active and non-active�
ingredients, devices, device components, CMOs and�
producers of other raw materials and supplies�
� Regulatory Compliance GAP analysis�
� Pre-inspection assessments for regulatory bodies, e.g., US�
FDA, EMA, JPAL, etc.�
� Audit Consultancy and training services�
GXP Auditing Services�
� Compliance audits for suppliers to ensure optimal�
quality is delivered to clients�
� Regulatory Compliance GAP analysis�
� Pre-inspection assessments for regulatory bodies,�
e.g., US FDA, EMA, JPAL, etc.�
� Audit Consultancy and training services�
Copyright © 2010 Quality Compliance Partners, Inc.�
Quality Compliance Partners, Inc.�
5519 Clairemont Mesa Blvd. #290�
San Diego, CA 92117�
www.qualpartners.com�
Life Science companies are facing increasing financial pressures to produce an acceptable return on investment (ROI).�
The cost of product development is increasing and the level of R&D productivity has declined. At the same time companies are facing cost�
containment measures by their investors. Loss of patent rights adds financial pressure. One of the many strategic options that�
pharmaceutical companies are adopting is to fill their R&D pipeline with in-licensed compounds from other companies.�
Part of the process of in-licensing compounds/products is to manage the inherent risk. Increasingly, companies that in-license�
compounds/ products that are under clinical development want to manage the risk by understanding more fully the clinical programs. Are�
the current programs robust? Will any of the programs need to be repeated?�
Clinical audits encompass all aspects of the clinical development�
process:�
� - Comprehensive review of essential�
documents according to ICH GCP, Directive 2001/20/EC and�
client SOPs.�
� - Audits of pivotal or supportive studies�
involving single or multiple investigator sites on a worldwide�
basis.�
� - Review of facilities, equipment,�
procedures and personnel, either pre-study or during study�
conduct.�
� - Pre-contractual audits,�
evaluation as preferred service providers or audits involving�
ongoing projects.�
� - Audit of a sample of data from a locked�
database according to either the client or QCP, Inc. Consulting�
SOPs.�
� - Audits of clinical reports against client�
SOPs and ICH GCP requirements.�
�GLP audits of facilities, studies and reports�
�Assessment of laboratories for compliance with GLP regulations�
�GCLP audits of central laboratories handling human samples only�
�Audits of bioanalytical laboratory facilities to GLP and GCLP�
�Training of clinical staff in the requirements of GLP and GCLP�
�Systems audits of both pre- and post-marketing�
pharmacovigilance activities�
�Mock pharmacovigilance inspections�
�Training for pharmacovigilance inspections�
�Documentation audits (e.g. PSURs, ASRs)�
�Database reconciliation audits (clinical and safety databases)�
�Gap analysis of pharmacovigilance procedures�
QCP, Inc. has the team, the experience, the skills and the competencies to�
conduct independent due diligence of a clinical or commercial product�
program to help companies understand and manage the associated risk.�
