Welcome to Our GMP Documentation Suite
Click Here to purchase the Full GMP Documentation Suite (50 + GMP SOPs, Forms and Work Instructions)
For Sale: Individual GMP SOPs for Equipment
E_0001 Setup and Operation of a Bosch Vial Washer
E_0002 Setup and Operation of a Bosch Depyrogenation Tunnel
E_0003 Setup and Operation of a Bosch Vial Filler
E_0004 Setup and Operation of a Bosch Vial Capper
E_0005 Setup and Operation of Steris Finn Aqua Autoclave
E_0006 Setup and Operation of a Crest Sonication Sink
E_0007 Setup and Operation of a Yokogawa Linear Chart Recorder
E_0008 Setup and Operation of EISAi Inspection systems
E_0009 Setup and Operation of Vial Vaccine Monitoring labeler
E_0010 Setup and Operation of a Jones Cartoner System
E_0011 Calibration of GMP Instruments
E_0012 Operation and Standardization of pH meters
E_0013 Operation and Maintenance of Spectrophotometers
E_0014 Operation and Maintenance for CPU Systems
For Sale: Individual GMP SOPs for Cleaning/Disinfection, Aseptic Processing and Chemical Safety
C_0001 Surface Disinfection in Aseptic Processing Areas
C_0002 Cleaning, Assembly and Wrapping of Vial Filling Equipment
C_0003 Aseptic Gowning Requirements and Certification
C_0004 Preparation and Use of Disinfectants
C_0005 Routine Cleaning and Housekeeping of Sterile Suites
C_0006 Cleanup and Handling of Spills (Hazardous Materials)
C_0007 Cleaning and disinfection of aseptic processing, classified, controlled and uncontrolled areas
C_0008 Handling of Controlled Substances
C_0009 Chemical Spill Cleanup
C_0010 Cleaning and Disinfection of Vial Filling Suites
C_0011 Exposure Control Plan for bloodborne pathogens
C_0012 Hazardous Waste Management
For Sale: Individual GMP SOPs for Validation and Qualification Activity
V_0002 Laboratory Instrument Qualification
V_0003 Validation Master Plan Management and Requirements
V_0004 Validation Project Plan Management
V_0006 Review of Qualification Protocols and Final Reports for Equipment
V_0008 Process Validation Protocols and Reports
V_0009 General Cleaning Validation Requirements
For Sale: Individual GMP SOPs for Quality and Documention
Q_0001 GMP Documentation Practices
Q_0002 Quality Control Responsibilities
Q_0003 Batch Record Authoring Processes
Q_0004 Equipment Cleaning and Usage Logging
Q_0005 Use, Control and Review of Laboratory Equipment Logbooks
For Sale: Individual GMP SOPs for Process Sampling/Testing and Environmental Monitoring
S_0001 Maintenance of Vial Challenge Sets for EISAi Inspection System
S_0002 Clean Steam Sampling
S_0003 Fill Finish Environmental Monitoring
S_0004 Performing In-Process Turbidity Testing with a Spectrophotometer
For Sale: Individual GMP SOPs for Flow of Materials/Personnel
F_0001 Control of Personnel, Material and Equipment Flow in Manufacturing Areas
F_0002 Prevention of cross-contamination in corridors during equipment transport
For Sale: Individual GMP Forms and Checklists
DCD_0001 Leak Test Form for Autoclave
DCD_0002 Bowie Dick Test Form for Autoclave
DCD_0003 Air Filter Steam in Place Checklist for Autoclave
DCD_0004 Room Cleaning Checklist
DCD_0005 Sonication, Assembly and Wrapping of Parts prior to Autoclaving
DCD_0006 Hand Cleaning, Assembly and Wrapping of Parts prior to Autoclaving
DCD_0007 Disposition of Uninspected Syringes
DCD_0008 Equipment Qualification Checklist
DCD_0009 Disposition of Uninspected Syringes
DCD_00010 Drum Assembly Checklist
Click Below to Purchase Full GMP Documentation Suite (50 + SOPs, Forms and Work Instructions)
Full GMP Documentation Suite (50 + MS Word Documents)
Individual GMP SOPs, Forms, Work Instructions and Templates are available for purchase/instant download in MS Word format. All documents are written in accordance with GMP guidelines and formatted using industry best practices. Upon processing of your order, your documents will be securely emailed to you!
Starting a New GMP facility? Save time and money and purchase our full documentation Suite!
Click Here to purchase the Full GMP Documentation Suite (50 + GMP SOPs, Forms and Work Instructions)
For Sale: Individual GMP SOPs for Equipment
E_0001 Setup and Operation of a Bosch Vial Washer
E_0002 Setup and Operation of a Bosch Depyrogenation Tunnel
E_0003 Setup and Operation of a Bosch Vial Filler
E_0004 Setup and Operation of a Bosch Vial Capper
E_0005 Setup and Operation of Steris Finn Aqua Autoclave
E_0006 Setup and Operation of a Crest Sonication Sink
E_0007 Setup and Operation of a Yokogawa Linear Chart Recorder
E_0008 Setup and Operation of EISAi Inspection systems
E_0009 Setup and Operation of Vial Vaccine Monitoring labeler
E_0010 Setup and Operation of a Jones Cartoner System
E_0011 Calibration of GMP Instruments
E_0012 Operation and Standardization of pH meters
E_0013 Operation and Maintenance of Spectrophotometers
E_0014 Operation and Maintenance for CPU Systems
For Sale: Individual GMP SOPs for Cleaning/Disinfection, Aseptic Processing and Chemical Safety
C_0001 Surface Disinfection in Aseptic Processing Areas
C_0002 Cleaning, Assembly and Wrapping of Vial Filling Equipment
C_0003 Aseptic Gowning Requirements and Certification
C_0004 Preparation and Use of Disinfectants
C_0005 Routine Cleaning and Housekeeping of Sterile Suites
C_0006 Cleanup and Handling of Spills (Hazardous Materials)
C_0007 Cleaning and disinfection of aseptic processing, classified, controlled and uncontrolled areas
C_0008 Handling of Controlled Substances
C_0009 Chemical Spill Cleanup
C_0010 Cleaning and Disinfection of Vial Filling Suites
C_0011 Exposure Control Plan for bloodborne pathogens
C_0012 Hazardous Waste Management
For Sale: Individual GMP SOPs for Validation and Qualification Activity
V_0002 Laboratory Instrument Qualification
V_0003 Validation Master Plan Management and Requirements
V_0004 Validation Project Plan Management
V_0006 Review of Qualification Protocols and Final Reports for Equipment
V_0008 Process Validation Protocols and Reports
V_0009 General Cleaning Validation Requirements
For Sale: Individual GMP SOPs for Quality and Documention
Q_0001 GMP Documentation Practices
Q_0002 Quality Control Responsibilities
Q_0003 Batch Record Authoring Processes
Q_0004 Equipment Cleaning and Usage Logging
Q_0005 Use, Control and Review of Laboratory Equipment Logbooks
For Sale: Individual GMP SOPs for Process Sampling/Testing and Environmental Monitoring
S_0001 Maintenance of Vial Challenge Sets for EISAi Inspection System
S_0002 Clean Steam Sampling
S_0003 Fill Finish Environmental Monitoring
S_0004 Performing In-Process Turbidity Testing with a Spectrophotometer
For Sale: Individual GMP SOPs for Flow of Materials/Personnel
F_0001 Control of Personnel, Material and Equipment Flow in Manufacturing Areas
F_0002 Prevention of cross-contamination in corridors during equipment transport
For Sale: Individual GMP Forms and Checklists
DCD_0001 Leak Test Form for Autoclave
DCD_0002 Bowie Dick Test Form for Autoclave
DCD_0003 Air Filter Steam in Place Checklist for Autoclave
DCD_0004 Room Cleaning Checklist
DCD_0005 Sonication, Assembly and Wrapping of Parts prior to Autoclaving
DCD_0006 Hand Cleaning, Assembly and Wrapping of Parts prior to Autoclaving
DCD_0007 Disposition of Uninspected Syringes
DCD_0008 Equipment Qualification Checklist
DCD_0009 Disposition of Uninspected Syringes
DCD_00010 Drum Assembly Checklist
Click Below to Purchase Full GMP Documentation Suite (50 + SOPs, Forms and Work Instructions)
Full GMP Documentation Suite (50 + MS Word Documents)