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#GMP Manuals and Practical Guidance
USD 5.00
#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
GMP SOP
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USD 7.00
#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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#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 051 USD 5
VAL MANUAL- 051 Implementation of Process Analytical Technology
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#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 052 USD 8
VAL MANUAL- 052 Validation of Process Analytical Technology System
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#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 029 USD 8
VAL MANUAL- 029 Examples and Approaches of Solvent Recovery Validation
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#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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#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
GMP SOP
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#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 022 USD 8
VAL MANUAL- 022 Process Validation Sampling for Non-Sterile Solid Dose Drug Products
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USD 7.00
#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
GMP SOP
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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
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USD 7.00
#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 7.00
#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
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USD 7.00
#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
GMP SOP
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#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 012 USD 8
VAL MANUAL- 012 Documentation to Foster Continuous Quality Verification
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 056 USD 6
QMS MANUAL- 056 Batch Confirmation Certification & Release by a Qualified Person within the EU
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 004 USD 6
VAL MANUAL- 004 Evaluating Non-Cleaned Equipment Hold Times for Cleaning Validation Medicinal Products
GMP SOP
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#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 7.00
#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
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 063 USD 8
QMS MANUAL- 063 Determining Testing Patterns and Acceptance Criteria for Analytical Method Transfers
GMP SOP
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USD 5.00
#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
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 054 USD 8
QMS MANUAL- 054 Implementation of Real Time Release
GMP SOP
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USD 4.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 053 USD 4
QMS MANUAL- 053 Study Based GLP QA Audit for Critical Phases
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 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 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 4.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 032 USD 4
MFG MANUAL - 032 Sterile & Non Sterile Vial Capping Operations
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 030 USD 8
MFG MANUAL - 030 Cold Chain Management of Biopharmaceutical Materials
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 027 USD 5
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
MFG MANUAL - 027 Water Activity Fundamentals and Applications in Pharmaceutical Operations
GMP SOP
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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 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 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 7.00
#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
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 013 USD 8
MFG MANUAL - 013 Validation of Lyophilization Processes
GMP SOP
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USD 7.00
#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 7.00
#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 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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