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#Manuals

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
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USD 5.00
#GMP Manuals and Practical Guidance#Sterile Non Sterile Manufacturing Operation Manual#MFG MANUAL - 002 USD 5
MFG MANUAL - 002 Management of Non-Sterile Active Pharmaceutical Ingredient Manufacturing Area
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USD 4.00
#GMP Manuals and Practical Guidance#Sterile Non Sterile Manufacturing Operation Manual#MFG MANUAL - 020 USD 4
MFG MANUAL - 020 Sanitant Rotation in a Routine Sanitization Program
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 018 USD 8
VAL MANUAL- 018 Potential Critical Packaging Process Parameters and Validation Practices
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USD 5.00
#GMP Manuals and Practical Guidance#Sterile Non Sterile Manufacturing Operation Manual#MFG MANUAL - 034 USD 5
MFG MANUAL - 034 Principles and Responsibilities for The Management of Change in Operations
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 020 USD 8
VAL MANUAL- 020 Process Validation Sampling Practices for Non-Sterile Liquid and Semi Solid Drug Products
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 015 USD 8
VAL MANUAL- 015 Inspection Attributes in Packaging Validation of Non-Sterile Drug Products
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#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 058 USD 8
VAL MANUAL- 058 Documentation and Records for Cleaning Activities and Evaluation
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USD 5.00
#GMP Auditor Training Manuals
Audit - 14 Auditing Microbiology and Sterility Testing Laboratory
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#GMP Manuals and Practical Guidance#Analytical Microbiology Laboratory Manuals#LAB MANUAL - 001 USD 8
LAB MANUAL - 001 Environmental Monitoring
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#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 011 USD 8
QMS MANUAL- 011 Procedure for Quality Management of Contractors
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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 Auditor Training Manuals
Audit - 06 Auditing a Change Management System
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USD 8.00
#GMP Manuals and Practical Guidance#Sterile Non Sterile Manufacturing Operation Manual#MFG MANUAL - 012 USD 8
MFG MANUAL - 012 Gamma Radiation Sterilization
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 001 USD 8
VAL MANUAL- 001 The Preparation of Validation Master Plan
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#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 045 USD 8
VAL MANUAL- 045 Access by Regulatory Authorities and Auditors to Electronic Records
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USD 5.00
#GMP Auditor Training Manuals
Audit - 08 Auditing a Documentation System
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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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USD 5.00
#GMP Auditor Training Manuals
Audit - 03 Auditing a Personnel & Training System
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#GMP Auditor Training Manuals
Audit - 20 Auditing an Aseptic Sterile Area
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#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 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 5.00
#GMP Manuals and Practical Guidance#Analytical Microbiology Laboratory Manuals#LAB MANUAL - 005 USD 5
LAB MANUAL - 005 Sterility Testing
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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
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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
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#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
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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
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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
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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 5.00
#GMP Manuals and Practical Guidance#Analytical Microbiology Laboratory Manuals#LAB MANUAL - 008 USD 5
LAB MANUAL - 008 Transfer of Analytical Methods
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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
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USD 5.00
#GMP Auditor Training Manuals
Audit - 17 Auditing an Active API Manufacturer
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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
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