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#Manuals
USD 4.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 024 USD 4
VAL MANUAL- 024 General Outline of Analytical Procedure Validation
GMP SOP
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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 4.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 020 USD 4
QMS MANUAL- 020 Material Status Indication
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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- 009 USD 8
VAL MANUAL- 009 Process Validation for Formulated Products
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 027 USD 8
VAL MANUAL- 027 Potential Critical Parameters for ProcessIinvolves in Formulating Solid Oral Dosage Forms
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 029 USD 5
MFG MANUAL - 029 Assessment of Shipping Processes for Drug Products
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 001 USD 8
MFG MANUAL - 001 Considerations for Selecting Packaging Lot Sizes During Packaging
GMP SOP
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USD 3.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 027 USD 3
QMS MANUAL- 027 Storage & Distribution of Drug Products and Medical Devices
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 008 USD 5
MFG MANUAL - 008 Clean Steam Systems
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 016 USD 5
MFG MANUAL - 016 Packaging System Integrity for Sterile Medical Devices
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 019 USD 6
MFG MANUAL - 019 Prevention and Control of Fungal Contamination in Tablets
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 015 USD 5
MFG MANUAL - 015 Lyophilizer Loading and Unloading Recommendations
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 059 USD 6
QMS MANUAL- 059 Evaluation Process Supporting Elimination of Defined Shipment Temperature Range
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 026 USD 5
VAL MANUAL- 026 Critical Parameters for Process Involves in Formulating Semi-Solid Dosage Forms
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 048 USD 8
VAL MANUAL- 048 Purified Water and Water for Injection System Commissioning and Qualification Sampling Plans
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 003 USD 8
VAL MANUAL- 003 Equivalency Comparison of Medicinal Product Validation Batch Data to Reference Batches
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 030 USD 8
VAL MANUAL- 030 Identification and Investigation of Test Deviations During Validation
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 046 USD 8
VAL MANUAL- 046 Material of Construction Documentation
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USD 6.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 025 USD 6
MFG MANUAL - 025 Use of Sterilized Goggles Within the Aseptic Processing Area
GMP SOP
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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
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 049 USD 6
VAL MANUAL- 049 Quality Considerations for Direct Impact Compressed Air and Nitrogen Systems
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 034 USD 6
QMS MANUAL- 034 Conducting Investigations in a GMP Site
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 042 USD 7
VAL MANUAL- 042 Component Level Impact Assessment for Information System Application
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 014 USD 6
VAL MANUAL- 014 Guidance on Selection Criteria of Dose and Toxicity Data
GMP SOP
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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
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 021 USD 6
MFG MANUAL - 021 Sterilization or Depyrogenation Validation for Non Product Components
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 006 USD 8
MFG MANUAL - 006 Alternatives to Formaldehyde Fogging of Clean Rooms
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 003 USD 8
QMS MANUAL- 003 Evaluation of Contaminant Options for Packing of Solid Dosage Forms
GMP SOP
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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
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 027 USD 5
MFG MANUAL - 027 Water Activity Fundamentals and Applications in Pharmaceutical Operations
GMP SOP
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USD 8.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 062 USD 8
VAL MANUAL- 062 Use of Process Analytical Technology in Process Validation
GMP SOP
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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
GMP SOP
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