A full set of 105 manufacturing SOPs and Policies that lay the foundation for an ISO 13485 and part 820 compliant quality management system that works in coordination with already established SOPs or implemented quality systems at your company. They are written to allow you to add them into your current quality system with little effort on your part. This allows your manufacturing operation to quickly come into compliance with the electronic device history record software system with a minimum of disruption. Since the requirements of these SOPs are built into InstantGMP™ MD, implementation and training is easy. This set of SOPs is included with the Purchase of InstantGMP™ MD and comes pre-loaded in the included Document Management System (DMS).
The full set includes 105 SOPs, Policies and templates that provides a quality system for any medical device manufacturing site.
SOP 0102 Standard Operating Procedures
SOP 0103 Document Management System
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| Policies for Medical Device Manufacturing Sites | ||
| POL-3100 | Corporate Policies | |
| POL-3101 | Email Policy | |
| POL-3102 | Glossary | |
| POL-3115 | InstantGMP Personnel | |
| POL-3118 | Equipment Design Guidelines | |
| POL-3119 | Utilities Design Guideline | |
| POL-3120 | Leadership Policy | |
| POL-3122 | Written Procedures Policy | |
| POL-3124 | Buildings, Facilities, Equipment Design and Installation Policy | |
| POL-3201 | Confidentiality Policy | |
| POL-3203 | Service Provider Policy | |
| POL-3207 | Risk Assessment | |
| POL-3208* | Project Initiation | |
| POL-3300* | InstantGMP Manufacturing | |
| POL-3301* | Electronic Records and Signatures Policy | |
| POL-3302 | Vendor Selection and Qualification | |
| POL-3303* | Material Control | |
| POL-3304* | Equipment Management | |
| P0L-3305 | Facility Management | |
| POL-3306* | InstantGMP Production System Strategy | |
| POL-3307* | Purchasing Requirements | |
| POL-3309 | Production Personnel | |
| POL-3501 | Records | |
| POL-3503 | Training Policy | |
| POL-3504 | Change Management | |
| POL-3506 | Analytical Method Evaluation | |
| POL-3507 | Analytical Specification Evaluation | |
| POL-3508 | Regulatory Readiness | |
| POL-3509 | Quality Management Policy | |
| POL-3510 | Quality Audits | |
| POL-3630 | Records Retention and Disposition | |
| General SOPs | ||
| SOP-3100* | Purchase Requisition | |
| SOP-3101* | Project Initiation | |
| SOP-3102* | Standard Operating Procedures | |
| SOP-3103* | Document Management System | |
| SOP-3104 | Change Control | |
| SOP-3105 | Adverse Events | |
| SOP-3106 | Clinical Trial Initiation | |
| SOP-3107 | Clinical Supply Material Release | |
| SOP-3108 | Policies | |
| SOP-3110 | Protocols | |
| Quality System SOPs | ||
| SOP-3202 | Compliance with Certification and Regulatory Requirements | |
| SOP-3203 | Quality Agreement Preparation | |
| SOP-3204 | Training Program | |
| SOP-3207 | Regulatory and Client Inspections | |
| SOP-3208* | Deviation Investigations | |
| SOP-3209 | Material Complaints Handling | |
| SOP-3210 | Corrective and Preventative Actions Program | |
| SOP-3211 | Product Recalls | |
| SOP-3212* | Program to Qualify Vendors | |
| SOP-3213 | Finished Product Disposition | |
| SOP-3214* | Material Disposition | |
| SOP-3215* | Tests | |
| SOP-3216* | Methods | |
| SOP-3220 | Stability Studies | |
| SOP-3221 | Documentation Practices | |
| SOP-3226 | Accountability and Feedback Process | |
| Materials SOPs | ||
| SOP-3300* | Specifications | |
| SOP-3302* | Material Types | |
| SOP-3303* | Material Receipt | |
| SOP-3304* | Material Status | |
| SOP-3305* | Material Sampling | |
| SOP-3306* | Material Inventory Control and Reconciliation | |
| SOP-3307 | Packaging Component Inspection | |
| SOP-3308* | Part # Assignment | |
| SOP-3310 | Retain Samples | |
| SOP-3311 | Clinical Supply Shipment to Study Sites | |
| SOP-3312 | Material Shipment | |
| SOP-3314* | In-Coming Materials Holding and Labeling | |
| SOP-3315* | Holding and Labeling of In-Process Materials | |
| SOP-3316* | Holding and Labeling of Packaging Components | |
| SOP-3317* | Holding of Labels | |
| SOP-3318* | Holding and Labeling of Finished Products | |
| Facility and Equipment SOPs | ||
| SOP-3400 | Qualification of Equipment, Facility and Systems (IQ/OQ) | |
| SOP-3401 | Performance Qualification of Systems (PQ) | |
| SOP-3402 | Facility Access and Security | |
| SOP-3403 | Warehouse and Production Area Cleaning and Maintenance | |
| SOP-3404 | Facility Start Up and Shut Down | |
| SOP-3405 | Equipment Receipt and System Manuals | |
| SOP-3406 | Equipment and Room Logs and Status Tagging | |
| SOP-3407 | Gowning and General Safety | |
| SOP-3408 | Equipment and Utensil Cleaning and Storage | |
| SOP-3409 | Equipment Cleaning Verification Program | |
| SOP-3410 | Environmental Monitoring | |
| SOP-3411 | Pest Control | |
| SOP-3412 | Environmental Chambers and Storage | |
| SOP-3413 | Equipment Calibration Program | |
| SOP-3414 | Equipment Maintenance Program | |
| SOP-3415 | Waste Control and Management | |
| SOP-3416 | Storage in Refrigerators or Freezers | |
| SOP-3417 | Clean Room Cleaning | |
| SOP-3418 | Grounds | |
| SOP-3420 | Facility Maintenance and Modifications | |
| SOP-3421 | Equipment Installation | |
| SOP-3422 | Utilities Maintenance and Modifications | |
| SOP-3423 | Change Protocol for Facilities, Equipment and Utilities | |
| Production SOPs | ||
| SOP-3600* | Device Master Record | |
| SOP-3601* | Device History Record | |
| Packaging and Labeling SOPs | ||
| SOP-3700 | Clinical Supply Label Preparation and Control | |
| Safety SOPs | ||
| SOP-3800 | Hazardous Chemicals: Handling, Storage, and Disposal | |
| SOP-3801 | Disaster Emergency Response | |
| SOP-3802 | Safety Inspections | |
| SOP-3803 | Equipment Lock/Out and Tag/Out | |
| Format Templates | ||
| TMPL-0001 | Policy Format | |
| TMPL-0100 | SOP Format | |
* Policies and SOPs that are needed for InstantGMP™ manufacturing sites.
For more information, contact Robert Pochadt at rpochadt@instantGMP.com