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#Manuals
USD 6.00
#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
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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
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USD 6.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 031 USD 7
VAL MANUAL- 031 Validation Activities during Technology Transfers
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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
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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
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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
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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
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USD 6.00
#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 5.00
#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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USD 6.00
#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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USD 6.00
#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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USD 6.00
#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 6.00
#GMP Manuals and Practical Guidance
#Process, Cleaning, Method Computer Validation
#VAL MANUAL- 011 USD 8
VAL MANUAL- 011 Documentation Models for Continuous Quality Verification
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USD 6.00
#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 6.00
#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 6.00
#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
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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- 028 USD 10
VAL MANUAL- 028 The validation of facilities and system
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USD 6.00
#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 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
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USD 6.00
#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
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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
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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
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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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USD 6.00
#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 4.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 061 USD 4
QMS MANUAL- 061 R&D QA Audits for Suppliers and Vendors
GMP SOP
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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
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USD 5.00
#GMP Manuals and Practical Guidance
#Quality Management Systems Manuals
#QMS MANUAL- 055 USD 5
QMS MANUAL- 055 Preventive Maintenance
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USD 6.00
#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 6.00
#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 6.00
#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 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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