Sample Medical Device/Good Manufacturing Practice (GMP) Model
Subpart A--General Provisions
Subpart B--Quality System Requirements
Management Responsibility
Establish and maintain adequate organizational structure
Define responsibilities, authority and interrelation of personnel involved in quality system
Ensure adequate resources are available
Appoint member of management to oversee establishment of quality system
Establish and maintain adequate organizational structure to ensure quality device manufacturing.
Establish policy and objectives for commitment to quality
Establish quality plan
Establish quality system procedures and instructions
Review and update quality policy
Review suitability and effectiveness of quality system
Personnel
Establish procedures for identifying training needs
Perform and document quality training
Quality Audit
Conduct quality audits
Establish procedures for quality audits
Subpart C--Design Controls
Review and update procedures for device design
Review plans for design and development acitivites
Subpart D--Document Controls
Review documents to ensure compliance with document management system requirements
Subpart E--Purchasing Controls
Evaluate suppliers for compliance with product requirements
Review supplier contracts
Subpart F--Identification and Traceability
Subpart G--Production and Process Controls
Inspection, Measuring and Test Equipment
Calibrate equipment
Verify that cailbrations are recorded on appropriate log sheets
Process Validation
Verify that validation procedures are being properly implemented
Review and update process validation procedures
Production and Process Controls
Review SOP's that define and control production
Conduct process monitoring
Inspect environmental control system(s)
Maintain equipment
Verify equipment meets specified requirements
Inspect equipment
Verify that defective manufacturing material has been removed and recorded on log sheet
Verify limitations or allowable tolerances are posted on or near equipment
Subpart H--Acceptance Activities
Acceptance Status
Receiving, In-Process and Finished Device Acceptance
Verify that incoming product is inspected and tested
Subpart I--Nonconforming Product
Subpart J--Corrective and Preventative Action
Subpart K--Labeling and Packaging Control
Device Labeling
Device Packaging
Subpart L--Handling, Storage, Distribution and Installation
Distribution
Handling
Installation
Storage
Subpart M--Records
Complaint Files
Device History Record
Devices Master Record
General Requirements
Quality System Record
Subpart N--Servicing
Subpart O--Statistical Techniques
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Sample Medical Device/Good Manufacturing Practice (GMP) Model
