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Current Good Manufacturing Practices (CGMPs)

Beckloff Associates has developed successful relationships throughout the world. Our experience has enabled us to be sensitive to communication and cultural differences existing among countries. Our strategy is to increase the financial return on research investments for our clients by designing and implementing scientific regulatory strategies that decrease development time and increase market years for health-care products.

We have conducted numerous manufacturing, testing, and packaging facility audits and have assisted companies in attaining compliance with CGMP regulations, which is essential for companies to develop and commercialize products in the United States, Europe, and Canada.

Current Good Manufacturing Practices (CGMPs) include:

• Worldwide CGMP plant audits (drug substances, drug products, medical devices)
• Contract laboratories audits
• Vendor qualification audits (e.g., calibration and maintenance companies)
• Design of CGMP compliance programs, including Standard Operating Procedure (SOP) development
• U.S. site audits per EU requirements for Cardinal Health Qualified Person release (QP release)
• Pre-Approval Inspection (PAI) readiness programs
• Consultation regarding CGMP facilities design
• Data integrity audits
• 21 CFR Part 11 compliance audits and programs
• Training courses

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