cGCP and cGMP Quality Support

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It doesn’t matter what type of Quality service you require; NECLLC can deliver. We

have over 50 years of cGMP/cGCP expertise employing risk based and phase appropriate approach to cGMP and cGCP Quality System and Operations execution and remediation.  

cGCP experience ranges from CRO and study oversight, investigator site, vendor, and internal/system audits that span a wide range of therapeutic areas, services, and geographic locations.  

cGMP experience ranges from audit program creation and execution,  product release, batch

record review, Quality System execution to full assessment and remediation of

Quality System Elements to creating training programs and driving and

implementation of a Quality Compliance function, supporting audits and

inspection readiness and assessing FDA trends. We do this while leveraging the

resources and infrastructure already in place.

We strive to cultivate transparent and collaborative partnerships with internal and external stakeholders to become a trusted resource on the analysis and interpretation of cGCP and cGMP requirements and health authority regulations.

 Quality Management System

• System/Process evaluations, enhancements and efficiency
• Simple or Complex, paper or electronic system creation, execution, evaluation,  and remediation.
• Change Control: Phase Appropriate tracking and oversight, accurate scoping of changes.
• Deviations: Robust investigations, Root Cause Analysis, product impact assessments execution and training.
• Corrective and Preventive Actions: Root cause and effectiveness monitoring and what to do if the corrective action is not effective.
• Supplier Approval and Qualification: Oversight of suppliers directly related tomaterial quality.
• Material Qualification: Risked based categorization of materials and components to determine testing and inspection requirements.
• Annual Product Quality Review: Assessment of any required changes to process, materials, or product specifications
• Training system creation, maintenance and execution: Effective competency-based training systems directly related to a decrease in human error.
•  Provide training on topics such as basic cGMP principles, risk-based quality management, inspection readiness/preparation, and Investigation root cause analysis and CAPA creation and management.
• More!

Quality Compliance:

• Internal Audit Program creation and execution,
• Supplier Audit Program Creation and Execution (with a direct link to material and supplier risk classifications).
• Training on Regulatory Intelligence, FDA observational and warning letter trends.  
• Mock PAI and PLI FDA Inspections to identify risks and allow risk controls prior to inspection 
• Full Inspection Readiness Program to include:

1. Facility readiness: How does your facility show?
2. Documentation readiness: Is the documentation adequate?
3. Personnel Readiness: How do people behave when Regulatory Authorities stop them in the hallways?
4.  SME Readiness: Are SME’s prepared to explain their systems with confidence?
5.  Logistics readiness: Can we ensure the accurate documents and people enter the front room?
6. Storyboards for complex discussions

Quality Operations:

• Batch Record Review process creation and execution
• Product Release process creation and execution
• Material Qualification and testing program creation and execution, sample plans and reduced testing programs.
• Risk based Calibration Program creation
• Collaborative and transparent partnerships with cross functional areas (MSAT, R&D, Manufacturing)

Clinical QA:

• Clinical study team quality and compliance support
• Procedural gap analyses and the creation or revision of internal processes/policies to ensure compliance with changing regulatory requirements.
• Clinical Quality event investigation and corrective action and preventative action (CAPA) implementation and resolution.
•  Provide training on topics such as basic GCP, GLP, GCLP principles, risk-based quality management, inspection readiness/preparation, and CAPA creation and management.
•  Regulatory authority inspection readiness, including planning and facilitating BIMOmock inspections
• Quality by design input into the creation and review of clinical study-related documents, e.g., monitoring plans, clinical study protocols, informed consent forms, investigational brochures, etc.
• Audits of clinical investigator sites, vendors, internal systems/processes, clinical study reports, and marketing authorization application documents
• Clinical vendor qualification and oversight