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.

	AUDITING (Internal and External) Tracking Systems and Follow-up
	CELL BANKS (Master and Working) Preparation, Qualification, and Stability Programs
	CHANGE CONTROL Integration with Document Systems
	DOCUMENT CONTROL AND RETENTION Document Formats and Numbering Issuance and Change Control
	ENVIRONMENTAL AND UTILITY MONITORING Master Plan, SOPs, and Protocols Establishment of Limits
	LABORATORY CONTROL Product Stability Programs Method Validation Programs Lab Compliance Programs
	MAINTENANCE AND CALIBRATION Work Order Generation and Tracking Out of Tolerance Programs
	MATERIALS MANAGEMENT Supplier Certification Programs Raw Material Specifications Warehousing - Quarantine through Release with Traceability
	PROCESS VALIDATION Integration with Process Development Master Plans, Protocols, Data Collection, Reports Cleaning processes
	PRODUCTION Batch Records Formatted for Ease of Use, Review and Approval Changeovers (Plant/Equipment) Effective Procedures
	QUALIFICATION Computer Systems Plant Equipment Analytical Lab Equipment
	QUALITY ASSURANCE Investigations and Corrective Actions Document Review and Approval Lot Dispositioning 21 CFR Part 11 Compliance
	TRAINING GLP/GMP Training On the Job Training