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Gxp Auditing Services 2010
- 1. GXP Auditing Services Withour expertise in GXP audits, can help all parties across the entire product life cycle, GXP Compliance Manufacturing and Supplier Audits manage and improve the quality of their products in a globally consistent, include, but are not limited to: reliable and efficient manner through services and solutions tailored v – Good Manufacturing Practices specifically for life science quality assurance. v – Good Laboratory Practices v – Good Clinical Practices The life science industry is faced with increasing regulation and guidance v Computerized Systems Audits on efficacy, quality, and safety during the entire life cycle of their v products. Quality departments are expected to control compliance of the v product life cycle, from incoming goods to the delivery of finished product. Ø Compliance audits of manufacturers of active and non-active Ø Compliance audits for suppliers to ensure optimal ingredients, devices, device components, CMOs and quality is delivered to clients producers of other raw materials and supplies Ø Regulatory Compliance GAP analysis Ø Regulatory Compliance GAP analysis Ø Pre-inspection assessments for regulatory bodies, Ø Pre-inspection assessments for regulatory bodies, e.g., US e.g., US FDA, EMA, JPAL, etc. FDA, EMA, JPAL, etc. Ø Audit Consultancy and training services Ø Audit Consultancy and training services Copyright © 2010 Quality Compliance Partners, Inc.
- 2. Clinical audits encompassall aspects of the clinical development process: Ø GLP audits of facilities, studies and reports Ø - Comprehensive review of essential Ø Assessment of laboratories for compliance with GLP regulations documents according to ICH GCP, Directive 2001/20/EC and Ø GCLP audits of central laboratories handling human samples only client SOPs. Ø Audits of bioanalytical laboratory facilities to GLP and GCLP Ø - Audits of pivotal or supportive studies Ø Training of clinical staff in the requirements of GLP and GCLP involving single or multiple investigator sites on a worldwide basis. Ø - Review of facilities, equipment, Ø Systems audits of both pre- and post-marketing procedures and personnel, either pre-study or during study pharmacovigilance activities conduct. Ø Mock pharmacovigilance inspections Ø - Pre-contractual audits, Ø Training for pharmacovigilance inspections evaluation as preferred service providers or audits involving Ø Documentation audits (e.g. PSURs, ASRs) ongoing projects. Ø Database reconciliation audits (clinical and safety databases) Ø - Audit of a sample of data from a locked Ø Gap analysis of pharmacovigilance procedures database according to either the client or QCP, Inc. Consulting SOPs. Ø - Audits of clinical reports against client SOPs and ICH GCP requirements. 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? 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. Quality Compliance Partners, Inc. 5519 Clairemont Mesa Blvd. #290 San Diego, CA 92117 www.qualpartners.com Copyright © 2010 Quality Compliance Partners, Inc.