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cGMP Defined



 

 

 

 

GMP Quality Systems Consulting

We specialize in helping small, start up firms establish efficient, cost effective quality systems that will pass inspection and produce high quality products.  We've also significantly improved existing systems at established firms, incorporating all the most recent regulatory concerns. In this fast paced regulatory environment, it is almost impossible to keep up with what is considered "current industry practice."  We make it our job to always know the latest expectations and can apply them to your specific situation.

We have expertise in all aspects of quality and can help your firm with everything from writing the SOPs, protocols and Master Plans needed to set up a new manufacturing facility to reviewing existing documents for compliance. We understand risk-based evaluation and use the fundamentals of scientific rationale to create systems that increase the effectiveness of your quality program while minimizing unnecessary paperwork.   All our systems will take into account both U.S. and European regulatory requirements.

We can help you implement or redesign any Quality System, including:

bulletAUDITING (Internal and External)
bulletTracking Systems and Follow-up

bulletCELL BANKS (Master and Working)
bulletPreparation, Qualification, and Stability Programs

bulletCHANGE CONTROL
bulletIntegration with Document Systems

bulletDOCUMENT CONTROL AND RETENTION
bulletDocument Formats and Numbering
bulletIssuance and Change Control

bulletENVIRONMENTAL AND UTILITY MONITORING
bulletMaster Plan, SOPs, and Protocols
bulletEstablishment of Limits

bulletLABORATORY CONTROL
bulletProduct Stability Programs
bulletMethod Validation Programs
bulletLab Compliance Programs

bulletMAINTENANCE AND CALIBRATION
bulletWork Order Generation and Tracking
bulletOut of Tolerance Programs

bulletMATERIALS MANAGEMENT
bulletSupplier Certification Programs
bulletRaw Material Specifications
bulletWarehousing - Quarantine through Release with Traceability

bulletPROCESS VALIDATION
bulletIntegration with Process Development
bulletMaster Plans, Protocols, Data Collection, Reports
bulletCleaning processes

bulletPRODUCTION
bulletBatch Records Formatted for Ease of Use, Review and Approval
bulletChangeovers (Plant/Equipment)
bulletEffective Procedures

bulletQUALIFICATION
bulletComputer Systems
bulletPlant Equipment
bulletAnalytical Lab Equipment

bulletQUALITY ASSURANCE
bulletInvestigations and Corrective Actions
bulletDocument Review and Approval
bulletLot Dispositioning
bullet21 CFR Part 11 Compliance

bulletTRAINING
bulletGLP/GMP Training
bulletOn the Job Training

 

 

 

FDA Current Trends

At a May FDA workshop on the application process in Bethesda, Maryland, Center for Biologics Evaluation and Research (CBER) Review Management Associate Director Robert Yetter reported that, as of January 1, six of twelve pending BLAs were being delayed because of manufacturing problems.

Gold Sheet
June 2002


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