Medical Device SOPs

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 provides a quality system for any medical device manufacturing site.

 SOP 0102 Standard Operating Procedures

 SOP 0103 Document Management System

Policies for Medical Device Manufacturing Sites
POL-3100Corporate Policies
POL-3101Email Policy
POL-3102Glossary
POL-3115InstantGMP Personnel
POL-3118Equipment Design Guidelines
POL-3119Utilities Design Guideline
POL-3120Leadership Policy
POL-3122Written Procedures Policy
POL-3124Buildings, Facilities, Equipment Design and Installation Policy
POL-3201Confidentiality Policy
POL-3203Service Provider Policy
POL-3207Risk Assessment
POL-3208*Project Initiation
POL-3300*InstantGMP Manufacturing
POL-3301*Electronic Records and Signatures Policy
POL-3302Vendor Selection and Qualification
POL-3303*Material Control
POL-3304*Equipment Management
P0L-3305Facility Management
POL-3306*InstantGMP Production System Strategy
POL-3307*Purchasing Requirements
POL-3309Production Personnel
POL-3501Records
POL-3503Training Policy
POL-3504Change Management
POL-3506Analytical Method Evaluation
POL-3507Analytical Specification Evaluation
POL-3508Regulatory Readiness
POL-3509Quality Management Policy
POL-3510Quality Audits
POL-3630Records Retention and Disposition
Quality and Continuous Improvement Statement
General SOPs
SOP-3100*Purchase Requisition
SOP-3101*Project Initiation
SOP-3102*Standard Operating Procedures
SOP-3103*Document Management System
SOP-3104Change Control
SOP-3105Adverse Events
SOP-3106Clinical Trial Initiation
SOP-3107Clinical Supply Material Release
SOP-3108Policies
SOP-3110Protocols
Quality System SOPs
SOP-3202Compliance with Certification and Regulatory Requirements
SOP-3203Quality Agreement Preparation
SOP-3204Training Program
SOP-3207Regulatory and Client Inspections
SOP-3208*Deviation Investigations
SOP-3209Material Complaints Handling
SOP-3210Corrective and Preventative Actions Program
SOP-3211Product Recalls
SOP-3212*Program to Qualify Vendors
SOP-3213Finished Product Disposition
SOP-3214*Material Disposition
SOP-3215*Tests
SOP-3216*Methods
SOP-3220Stability Studies
SOP-3221Documentation Practices
SOP-3226Accountability 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-3307Packaging Component Inspection
SOP-3308*Part # Assignment
SOP-3310Retain Samples
SOP-3311Clinical Supply Shipment to Study Sites
SOP-3312Material 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-3400Qualification of Equipment, Facility and Systems (IQ/OQ)
SOP-3401Performance Qualification of Systems (PQ)
SOP-3402Facility Access and Security
SOP-3403Warehouse and Production Area Cleaning and Maintenance
SOP-3404Facility Start Up and Shut Down
SOP-3405Equipment Receipt and System Manuals
SOP-3406Equipment and Room Logs and Status Tagging
SOP-3407Gowning and General Safety
SOP-3408Equipment and Utensil Cleaning and Storage
SOP-3409Equipment Cleaning Verification Program
SOP-3410Environmental Monitoring
SOP-3411Pest Control
SOP-3412Environmental Chambers and Storage
SOP-3413Equipment Calibration Program
SOP-3414Equipment Maintenance Program
SOP-3415Waste Control and Management
SOP-3416Storage in Refrigerators or Freezers
SOP-3417Clean Room Cleaning
SOP-3418Grounds
SOP-3420Facility Maintenance and Modifications
SOP-3421Equipment Installation
SOP-3422Utilities Maintenance and Modifications
SOP-3423Change Protocol for Facilities, Equipment and Utilities
Production SOPs
SOP-3600*Device Master Record
SOP-3601*Device History Record
Packaging and Labeling SOPs
SOP-3700Clinical Supply Label Preparation and Control
Safety SOPs
SOP-3800Hazardous Chemicals: Handling, Storage, and Disposal
SOP-3801Disaster Emergency Response
SOP-3802Safety Inspections
SOP-3803Equipment Lock/Out and Tag/Out
Format Templates
TMPL-0001Policy Format
TMPL-0100SOP Format

* Policies and SOPs that are needed for InstantGMP™ manufacturing sites.

For more information, contact Robert Pochadt at rpochadt@instantGMP.com