The core set of SOPs is designed to work in coordination with an existing set of SOPs or a legacy quality system at your company. They are written to allow you to add them to 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, implementation and training are easy.
The core set of just the 23 SOPs and 7 Policies cover the basics of manufacturing with InstantGMP™ MES. This set is available at a discounted price.
SOP 0102 Standard Operating Procedures
SOP 0103 Document Management System
Policies for GMP Manufacturing Sites | |
POL-0208 | Project Initiation |
POL-0300 | InstantGMP™ Manufacturing |
POL-0301 | Electronic Records and Signature Policy |
POL-0303 | Material Control |
POL-0304 | Equipment Management |
POL-0306 | InstantGMP™ Production System Strategy |
POL-0307 | Purchasing Requirements |
General SOPs | |
SOP-0100 | Purchase Requisition |
SOP-0101 | Project Initiation |
SOP-0102 | Standard Operating Procedures |
SOP-0103 | Document Management System |
SOP-0208 | Deviations |
SOP-0212 | Program to Qualify Vendors |
SOP-0214 | Material Disposition |
SOP-0215 | Tests |
SOP-0216 | Methods |
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-0308 | Part Number Assignment |
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 |
Production SOPs | |
SOP-0600 | Master Production Record |
SOP-0601 | Batch Production Record |
SOP-0602 | Inventory Management During Batch Production |
For more information, contact Robert Pochadt at: rpochadt@InstantGMP.com or call (215) 968-5414.