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#Manual
USD 6.00
#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 5.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 057 USD 5
QMS MANUAL- 057 Cross Contamination Risk Evaluation Process for Commercial Compounds
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#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 062 USD 7
QMS MANUAL- 062 Certificate of Analysis & Certificate of Manufacture
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USD 6.00
#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)
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#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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#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 6.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 066 USD 7
QMS MANUAL- 066 Risk Management Application to Establishment of Weighing Device Performance Testing Intervals
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
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 054 USD 8
QMS MANUAL- 054 Implementation of Real Time Release
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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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#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 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 6.00
#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 6.00
#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 6.00
#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 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 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 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
#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 5.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 027 USD 5
LAB MANUAL - 027 Analytical Procedures and Validation
GMP SOP
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USD 4.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 014 USD 4
LAB MANUAL - 014 R&D GLP QA Record Retention Procedure
GMP SOP
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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
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 004 USD 5
MFG MANUAL - 004 Installation, Use and Maintenance of Metal Detectors in Pharmaceutical
GMP SOP
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USD 6.00
#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
GMP SOP
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USD 6.00
#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 6.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 013 USD 6
LAB MANUAL - 013 Commercial Stability Studies at Contractors
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 011 USD 5
LAB MANUAL - 011 Controlling the Microbiological Quality of Solid Oral Dosage Forms
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 003 USD 8
LAB MANUAL - 003 Water Quality Standard
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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