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#Guidance

USD 8.00
#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 015 USD 8
QMS MANUAL- 015 GMP Training System
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 025 USD 8
VAL MANUAL- 025 Periodic Review Process of Validated Equipment and Computer Systems in Pharmaceutical Industry
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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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USD 10.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 028 USD 10
VAL MANUAL- 028 The validation of facilities and system
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 036 USD 8
VAL MANUAL- 036 Information Technology Infrastructure Qualification
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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#Quality Management Systems Manuals#QMS MANUAL- 042 USD 8
QMS MANUAL- 042 Reduced Testing Program
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 008 USD 8
VAL MANUAL- 008 In-Process and Bulk Drug Product Holding Times
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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
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USD 8.00
#GMP Manuals and Practical Guidance#Analytical Microbiology Laboratory Manuals#LAB MANUAL - 012 USD 8
LAB MANUAL - 012 Commercial Stability Testing of API (Pure Bulk Drug)
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USD 8.00
#GMP Manuals and Practical Guidance#Sterile Non Sterile Manufacturing Operation Manual#MFG MANUAL - 014 USD 8
MFG MANUAL - 014 Retreatment and Blending of API & Formulated Product
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USD 5.00
#GMP Manuals and Practical Guidance#Analytical Microbiology Laboratory Manuals#LAB MANUAL - 021 USD 5
LAB MANUAL - 021 Microbiological Testing in Cleaning Validation for APIs and Drug Products
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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 5.00
#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 049 USD 5
QMS MANUAL- 049 Release of API Bulk Formulated Products & Part Finished Packs
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USD 7.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 035 USD 7
VAL MANUAL- 035 Non-Sterile API Manufacturing Area Environmental Control
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USD 8.00
#GMP Manuals and Practical Guidance#Analytical Microbiology Laboratory Manuals#LAB MANUAL - 020 USD 8
LAB MANUAL - 020 Manufacture and Microbiological Testing of Sterile API & Drug Product Within R&D
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USD 6.00
#GMP Manuals and Practical Guidance#Sterile Non Sterile Manufacturing Operation Manual#MFG MANUAL - 031 USD 6
MFG MANUAL - 031 Labeling and Packaging of Investigational Medicinal Products and APIs in R&D
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USD 10.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 061 USD 10
VAL MANUAL- 061 Cleaning Validation and Verification of Equipments Used for Manufacturing Active Pharmaceutical Ingredients
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USD 12.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 013 USD 12
VAL MANUAL- 013 Cleaning and Cleaning Validation of API Plant and Equipment
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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)
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USD 8.00
#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 065 USD 8
QMS MANUAL- 065 Determination of Storage Periods for API Excipients Intermediates and Raw Materials
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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 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 034 USD 8
VAL MANUAL- 034 Demonstration and Calculation of Equivalence Criteria of Impurities for API Process Validation
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 060 USD 8
VAL MANUAL- 060 Process Validation Approaches for Formulated Medicinal Products and Medical Devices
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 056 USD 8
VAL MANUAL- 056 Rinsate and Swab Sampling Procedure in Test Method Development and Validation
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 033 USD 8
VAL MANUAL- 033 Validation Documentation
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USD 6.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 050 USD 6
VAL MANUAL- 050 Systems Validation
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USD 8.00
#GMP Manuals and Practical Guidance#Process, Cleaning, Method Computer Validation#VAL MANUAL- 038 USD 8
VAL MANUAL- 038 Validation Considerations for Transportation of Biopharmaceutical Materials
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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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USD 5.00
#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 058 USD 5
QMS MANUAL- 058 Calibration
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USD 8.00
#GMP Manuals and Practical Guidance#Sterile Non Sterile Manufacturing Operation Manual#MFG MANUAL - 007 USD 8
MFG MANUAL - 007 Maintenance and Calibration of GMP Critical Item
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USD 8.00
#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 013 USD 8
QMS MANUAL- 013 Training system for Aseptic and Preparation forAseptic Operators and Support Staff
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USD 4.00
#GMP Manuals and Practical Guidance#Sterile Non Sterile Manufacturing Operation Manual#MFG MANUAL - 011 USD 4
MFG MANUAL - 011 Defining Worst Case Conditions for Aseptic Process Simulations
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USD 5.00
#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 018 USD 5
QMS MANUAL- 018 Quality and Compliance Auditing
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USD 8.00
#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 006 USD 8
QMS MANUAL- 006 Statistical Rationale for Raw Material Sampling
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USD 3.00
#GMP Manuals and Practical Guidance#Quality Management Systems Manuals#QMS MANUAL- 029 USD 3
QMS MANUAL- 029 Compliance Improvements Plans
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