cGxP

Consulting

 

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2: Quality System Improvement Plan (QSIP):

Negotiation and Remediation

 
We work with the client to develop Quality Systems Improvement Plans (QSIP)
Working towards “Buy In” for change
  • Grass - Roots Interface
     
  • Establish a regimen to ensure that due diligence is documented as the corrective and preventive actions are instituted on a practical timeline.

The development, negotiation, implementation, training, control and maintenance of the quality and compliance systems employed by the manufacturer is essential to assure that the product is safe and effective.

cGxP works with your company on a prospective basis or in response to regulatory actions. We offer support for planning, developing and implementing quality and compliance systems that are tailored to your business needs and in compliance with global regulations. We will help you identify weaknesses in your systems and provide you the solutions to overcome them. cGxP will upgrade or develop systems that meet business needs, the product liability environment and Worldwide Regulatory expectations. These include:

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  • Quality and Compliance Systems
    Policies and procedures (SOPs, BPs, OPs)

  • Specifications

  • Master batch records

  • Employee training

  • Good Documentation Practices

  • Annual product reviews

  • Laboratory testing and controls

  • Corrective and Preventive Actions (CAPA)

  • Production and Process Controls

  • Design Controls

  • Management Responsibility

  • Material Controls

  • Equipment and Facility Controls

  • Records, Documents and Change Controls

  • Independent third-party

  • GCP, GLP, GMP 

  • Management and Management Review Gap Analyses

  • Pre-Approval Inspections

  • Quality Assurance Master Plans

  • QC/ QA Assessment

  • Systems, Policies, Procedures

  • Specifications (liability implication), Master batch Records, Statistical Process Control,

  • Process Capability

  • Vendors and Contractors Approval (supplier qualification)

  • R&QE

  • Out of Specification, Deviations, Recording Original Data, Calculations and Rounding

  • Design Controls

  • Design and Engineering Reviews, Product Development Reviews

 

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