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#Guidance
USD 6.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 005 USD 5
LAB MANUAL - 005 Sterility Testing
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 016 USD 8
LAB MANUAL - 016 Microbiological Testing for Non Sterile Drug Product
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USD 5.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 010 USD 5
MFG MANUAL - 010 Container Closure Integrity for Sterile Drug Products
GMP SOP
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USD 5.00
#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
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 006 USD 6
LAB MANUAL - 006 Endotoxin Testing
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USD 7.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 023 USD 8
MFG MANUAL - 023 Unplanned Cleanroom Power Outage Time Limit and Recovery
GMP SOP
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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
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Sterile Non Sterile Manufacturing Operation Manual
#MFG MANUAL - 012 USD 8
MFG MANUAL - 012 Gamma Radiation Sterilization
GMP SOP
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USD 5.00
#GMP Manuals and Practical Guidance
#Analytical Microbiology Laboratory Manuals
#LAB MANUAL - 028 USD 5
LAB MANUAL - 028 Microbial Attributes of Non Sterile Solid Materials Testing
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 006 USD 8
VAL MANUAL- 006 Evaluation of Changes for Potential Impact on Process Validation
GMP SOP
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USD 7.00
#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
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 053 USD 10
VAL MANUAL- 053 Calculations of Residue Limits for Medicinal Product for Equipment Cleaning During Cleaning Validation
GMP SOP
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USD 7.00
#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 6.00
#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 7.00
#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 7.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 041 USD 7
QMS MANUAL- 041 Risk Management in the Quality and Compliance Area
GMP SOP
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USD 7.00
#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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USD 5.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 031 USD 5
QMS MANUAL- 031 Control of Manufacturing and Packaging Defects Non Sterile
GMP SOP
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USD 3.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 028 USD 3
QMS MANUAL- 028 Facility Based R&D QA Audit
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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
GMP SOP
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USD 6.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 025 USD 6
QMS MANUAL- 025 Weighing and Measuring Practices In Manufacturing Operations
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 054 USD 8
VAL MANUAL- 054 Procedure for Identification and Sampling of Swab and Visual Inspection Locations for Medicinal Products and API Equipment
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 007 USD 8
QMS MANUAL- 007 Certificate of Materials Supplied to Receiving Site
GMP SOP
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USD 7.00
#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
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 055 USD 8
VAL MANUAL- 055 How to Group Product and Equipment and Select the Worst Case Product in Cleaning Validation
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 057 USD 8
VAL MANUAL- 057 Method of Visual Inspection and Quantitation in Cleaning Validation
GMP SOP
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USD 7.00
#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 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 050 USD 6
VAL MANUAL- 050 Systems Validation
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 041 USD 7
VAL MANUAL- 041 Clean Pure Steam System Commissioning and Qualification Approaches & Sampling Plans
GMP SOP
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USD 7.00
#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 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 043 USD 8
VAL MANUAL- 043 Cycle Validation for Freeze Drying
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 040 USD 8
VAL MANUAL- 040 Management of Change in Computerised System
GMP SOP
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USD 7.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 031 USD 7
VAL MANUAL- 031 Validation Activities during Technology Transfers
GMP SOP
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USD 4.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 037 USD 4
VAL MANUAL- 037 How to Investigate Unknown Chromatographic Peaks during Cleaning Validation Activity
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 5.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 047 USD 5
VAL MANUAL- 047 Packaging Process Documentation Transfer for Drug Products
GMP SOP
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