January 25, 2016

SOPs Full Set

The FDA mandates that dietary supplement implement and follow a full set of SOPs as part of a quality system. A full set of manufacturing SOPs is available to work in coordination with your existing SOPs or your 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 systems with a minimum of disruption. Since the requirements of these SOPs are built into InstantGMP™ MES and InstantGMP™ Vape, implementation and training is easy.

The full set includes over 110 SOPs, Policies and templates that provides a quality system for any GMP manufacturing site.

 SOP 0102 Standard Operating Procedures

 SOP 0103 Document Management System

  Policies for GMP Manufacturing Sites
POL-0100 Corporate Policies
POL-0101 Email Policy
POL-0102 Glossary
POL-0115 InstantGMP™ Personnel
POL-0118 Equipment Design Guideline
POL-0119 Utility Design Guideline
POL-0120 Leadership Policy
POL-0122 Written Procedures
POL-0124 Buildings, Facilities, Equipment Design, and Installation Policy
POL-0201 Confidentiality Policy
POL-0203 Service Provider Policy
POL-0207 Risk Assessment Policy
POL-0208* Project Initiation
POL-0300* InstantGMP™ Manufacturing
POL-0301* Electronic Records and Signatures Policy
POL-0302 Vendor Selection and Qualification
POL-0303* Material Control
POL-0304* Equipment Management
POL-0305 Facility Management
POL-0306* InstantGMP™ Production System Strategy
POL-0307* Purchasing Requirements
POL-0309 Production Personnel
POL-0500 Document Storage
POL-0501 Records
POL-0503 Training Policy
POL-0504 Change Management
POL-0506 Analytical Method Evaluation
POL-0507 Analytical Specification Evaluation
POL-0508 Regulatory Readiness
POL-0509 Quality Management System
POL-0510 Quality Audits
POL-0603 Records Retention and Disposition
  Quality and Continuous Improvement Statement
   
  General SOPs
SOP-0100* Purchase Requisition
SOP-0101* Project Initiation
SOP-0102* Standard Operating Procedures
SOP-0103* Document Management System
SOP-0104 Change Control
SOP-0105 Adverse Events
SOP-0106 Clinical Trial Initiation
SOP-0107 Clinical Supply Material Release
SOP-0108 Policies
SOP-0110 Protocols
   
  Quality System SOPs
SOP-0202 Compliance with Certification and Regulatory Requirements
SOP-0203 Quality Agreement Preparation
SOP-0204 Training Program
SOP-0207 Regulatory and Client Inspections
SOP-0208* Deviation Investigations
SOP-0209 Material Complaints Handling
SOP-0210 Corrective and Preventative Actions Program
SOP-0211 Product Recalls
SOP-0212* Program to Qualify Vendors
SOP-0213 Finished Product Disposition
SOP-0214* Material Disposition
SOP-0215* Tests
SOP-0216* Methods
SOP-0220 Stability Studies
SOP-0221 Documentation Practices
SOP-0226 Accountability and Feedback Process
   
  Material SOPs
SOP-0300* Specifications
SOP-0302* Material Types
SOP-0303* Material Receipt
SOP-0304* Material Status
SOP-0305* Material Sampling
SOP-0306* Material Inventory Control and Reconciliation
SOP-0307 Packaging Component Inspection
SOP-0308* Part Number Assignment
SOP-0310 Retain Samples
SOP-0311 Clinical Supply Shipment to Study Sites
SOP-0312 Material Shipment
SOP-0314* Incoming Materials Holding and Labeling
SOP-0315* Holding and Labeling of In-Process Materials
SOP-0316* Holding and Labeling of Packaging Components
SOP-0317* Holding of Labels
SOP-0318* Holding and Labeling of Finished Products
   
  Facility and Equipment SOPs
SOP-0400 Qualification of Equipment, Facility, and Systems (IQ/OQ)
SOP-0401 Performance Qualification of Systems (PQ)
SOP-0402 Facility Access and Security
SOP-0403 Warehouse and Production Area Cleaning and Maintenance
SOP-0404 Facility Start-up and Shut-down
SOP-0405 Equipment Receipt and System Manuals
SOP-0406 Equipment and Room Logs and Status Tagging
SOP-0407 Growing and General Safety
SOP-0408 Equipment and Utensil Cleaning and Storage
SOP-0409 Equipment Cleaning Verification Program
SOP-0410 Environmental Monitoring
SOP-0411 Pest Control
SOP-0412 Environmental Chambers and Storage
SOP-0413 Equipment Calibration Program
SOP-0415 Waste Control Management
SOP-0416 Storage in Refrigerators or Freezers
SOP-0417 Clean Room Cleaning
SOP-0418 Grounds
SOP-0420 Facility Management and Modification
SOP-0421 Equipment Installation
SOP-0422 Utility Management Program
SOP-0423 Change Control for Facility, Equipment, and Utilities
SOP-0426 Products Returns
SOP-0427 Class 100 Clean Room Cleaning
   
  Computer System SOPs
SOP-0500 Computer System Inventory
SOP-0501 Computer System Operation
SOP-0502 Computer System Security
SOP-0503 Computer System Validation
SOP-0504 Electronic Signatures
   
  Production SOPs
SOP-0600* Master Production Record
SOP-0601* Batch Production Record
SOP-0602* Inventory Management During Batch Production
   
  Packaging and Labeling SOPs
SOP-0700 Clinical Supply Label Preparation and Control
   
  Safety SOPs
SOP-0800 Hazardous Chemicals: Handling, Storage, and Disposal
SOP-0801 Disaster Emergency Response
SOP-0802 Safety Inspections
SOP-0803 Equipment Lock/Out and Tag/Out
   
  Format Templates
TMPL-0001 Policy Format
TMPL-0100 SOP Format


For more information, contact Robert Pochadt at:
rpochadt@InstantGMP.com or call (215) 968-5414.* Policies and SOPs that are needed for InstantGMP™ manufacturing sites.