January 26, 2016

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.

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-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-3123 Validation and Change Control 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
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-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