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#Guidance
USD 4.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 018 USD 4
MFG MANUAL - 018 In-Process Testing, Checks and Sampling
GMP SOP
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USD 4.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 007 USD 4
VAL MANUAL- 007 Swab and Visual Inspection Sampling Locations Guidance for Process Equipment
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#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 023 USD 4
QMS MANUAL- 023 Receipt, Approval and Use of Labels and Labeling
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USD 8.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 008 USD 8
QMS MANUAL- 008 Quality Risk Management Application Critical Instrument Calibration
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#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 046 USD 8
QMS MANUAL- 046 Supplier Auditing for GMP Facility
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USD 5.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 001 USD 5
QMS MANUAL- 001 Release For Commercial Use of Drug Product and API Pre-Validation and Validation Batches
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USD 7.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 050 USD 7
QMS MANUAL- 050 Computerized Systems Risk Management
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USD 4.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 038 USD 4
QMS MANUAL- 038 Definition and Documentation of Raw Data
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USD 8.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 002 USD 8
LAB MANUAL - 002 Analytical Laboratory Management
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USD 4.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 061 USD 4
QMS MANUAL- 061 R&D QA Audits for Suppliers and Vendors
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USD 6.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 013 USD 6
LAB MANUAL - 013 Commercial Stability Studies at Contractors
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USD 8.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 003 USD 8
MFG MANUAL - 003 Manufacturing Documentation
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 005 USD 5
LAB MANUAL - 005 Sterility Testing
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 004 USD 8
LAB MANUAL - 004 Microbiology Laboratory Management
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USD 6.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 006 USD 6
LAB MANUAL - 006 Endotoxin Testing
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 028 USD 8
MFG MANUAL - 028 Requirements for Facilities For Sterile and Non-sterile Drug Manufacture
GMP SOP
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USD 3.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 032 USD 3
QMS MANUAL- 032 Pest Control
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USD 5.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 048 USD 5
QMS MANUAL- 048 Artwork Creation & Control of Printed Packaging Components
GMP SOP
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USD 4.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 022 USD 4
MFG MANUAL - 022 Returned Goods
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 024 USD 5
MFG MANUAL - 024 Receipt Handling and Storage of Starting & Packaging Materials
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 026 USD 7
MFG MANUAL - 026 Control of Packaging Operation
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 005 USD 8
MFG MANUAL - 005 Storage, Handling and Cleaning of Hoses Used in Pharmaceutical Production
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 018 USD 8
LAB MANUAL - 018 Laboratory Equipment Qualification - PART 1
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 019 USD 8
LAB MANUAL - 019 Laboratory Equipment Qualification - PART 2
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 044 USD 8
VAL MANUAL- 044 Documenting IQ, OQ, PQ Protocol Test Results for Equipment, Facility and Computer
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USD 8.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 001 USD 8
LAB MANUAL - 001 Environmental Monitoring
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USD 8.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 051 USD 8
QMS MANUAL- 051 Quality Risk Management Application to Identify Deviations vs. Events
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 008 USD 5
LAB MANUAL - 008 Transfer of Analytical Methods
GMP SOP
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USD 4.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 033 USD 4
MFG MANUAL - 033 Use and Recovery of Solvents in API Manufacturing
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 007 USD 8
LAB MANUAL - 007 Guideline for Stability Testing for R&D
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USD 6.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 025 USD 6
LAB MANUAL - 025 Stability Considerations for Planned or Unplanned API Process Changes
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 032 USD 8
VAL MANUAL- 032 Validation Considerations for Re-work and Re-process of API
GMP SOP
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USD 4.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 037 USD 4
VAL MANUAL- 037 How to Investigate Unknown Chromatographic Peaks during Cleaning Validation Activity
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 011 USD 8
VAL MANUAL- 011 Documentation Models for Continuous Quality Verification
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 005 USD 7
VAL MANUAL- 005 Process Validation of Bulk Drug (API and Intermediate)
GMP SOP
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USD 4.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 023 USD 4
VAL MANUAL- 023 Performance Qualification versus Process Validation
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