Quality in e-liquid manufacturing starts with making batches consistently and to defined standards. This set of standard operating procedures and policies is designed to work in coordination with InstantGMP™ Vape to provide an essential quality system at your company. This allows your manufacturing operation to quickly come into compliance with the electronic systems and a quality-based manufacturing system with a minimum of disruption. Since the requirements of these SOPs are built into InstantGMP™ Vape, implementation and training are easy.
The full set includes 81 SOPs, Policies and templates that provide a quality system for any e-liquid manufacturing site.
SOP 0102 Standard Operating Procedures
SOP 0103 Document Management System
Policies for GMP Manufacturing Sites | ||
POL-2100 | Corporate Policies | |
POL-2101 | Email Policy | |
POL-2102 | Glossary | |
POL-2201 | Confidentiality Policy | |
POL-2203 | Service Provider Policy | |
POL-2208 | Project Initiation | |
POL-0300 | InstantGMP Manufacturing | |
POL-2301 | Electronic Records and Signatures Policy | |
POL-2306 | InstantGMP Production System Strategy | |
POL-2309 | Production Personnel | |
POL-2500 | Document Storage Policy | |
POL-2503 | Training Policy | |
POL-2504 | Change Management | |
POL-2630 | Records Retention and Disposition | |
General SOPs | ||
S2100 | Purchase Requisition | |
S2101 | Project Initiation | |
S2102 | Standard Operating Procedures | |
S2103 | Document Management System | |
S2104 | Change Control | |
S2108 | Policies | |
Quality System SOPs | ||
S2204 | Training Program | |
S2206 | Investigations | |
S2207 | Regulatory and Client Inspections | |
S2208 | Deviations | |
S2209 | Material Complaint Handling | |
S2210 | Corrective and Preventative Actions Program | |
S2211 | Product Recalls | |
S2214 | Material Disposition | |
S2215 | Tests | |
S2216 | Methods | |
S2221 | Documentation Practices | |
Materials SOPs | ||
S2300 | Specifications | |
S2302 | Material Types | |
S2303 | Material Receipt | |
S2304 | Material Status | |
S2306 | Material Inventory Control and Reconciliation | |
S2307 | Packaging and Label Inspection | |
S2308 | Part # Assignment | |
S2310 | Retain Samples | |
S2312 | Material Shipment | |
Facility and Equipment SOPs | ||
S2402 | Facility Standards, Access and Security | |
S2403 | Warehouse and Production Area Cleaning and Maintenance | |
S2404 | Facility Start Up and Shut Down | |
S2405 | Equipment Receipt and System Manuals | |
S2406 | Equipment and Room Logs and Status Tagging | |
S2407 | Gowning and General Safety | |
S2408 | Equipment and Utensil Cleaning and Storage | |
S2409 | Equipment Cleaning Verification Program | |
S2410 | Environmental Monitoring | |
S2411 | Pest Control | |
S2413 | Equipment Calibration Program | |
S2415 | Waste Control and Management | |
S2417 | Clean Room Cleaning | |
S2416 | Grounds | |
Production SOPs | ||
S2600 | Master Production Record | |
S2601 | Batch Production Record | |
S2602 | Packaging and Labeling of E-Liquids | |
Safety SOPs | ||
S2800 | Hazardous Chemicals: Handling, Storage, and Disposal | |
Format Templates | ||
TMPL-0001 | Policy Format | |
TMPL-0100 | SOP Format |
POL-2115 | InstantGMP Personnel |
POL-2118 | Equipment Design Guidelines |
POL-2119 | Utilities Design Guidelines |
POL-2120 | Leadership Policy |
POL-2122 | Written Procedures |
POL-2124 | Buildings, Facilities, Equipment Design and Installation |
POL-2207 | Risk Assessment |
POL-2300 | InstantGMP Manufacturing |
POL-2302 | Vendor Selection and Qualification |
POL-2303 | Material Control |
POL-2304 | Equipment Management |
POL-2305 | Facility Management |
POL-2306 | iGMP Production System Strategy |
POL-2307 | Purchasing Requirements |
POL-2506 | Analytical Method Evaluation |
POL-2507 | Analytical Specification Evaluation |
POL-2508 | Regulatory Readiness |
POL-2509 | Quality Management System |
POL-2510 | Quality Audits |
Quality and Continuous Improvement Statement |
SOP-2202.00 | Compliance with Certification and Regulatory Requirements. |
SOP-2203.00 | Quality Agreement Preparation |
SOP-2207.00 | Regulatory and Client Inspections |
SOP-2305.00 | Material Sampling |
SOP-2400.00 | Qualification of Facility, Equipment and Systems |
SOP-2401.00 | Performance Qualification of Systems |
For more information, contact Robert Pochadt at: rpochadt@InstantGMP.com or call (215) 968-5414.