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Search results for: 'regulatory cooperation expanded between fda, ec and_n15'

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  1. NDA Field Alert Version 03 - GMP SOP
    NDA Field Alert Version 03 - GMP SOP
    Rating:
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    1 Review
    Regular Price $120.00 Today $99.00
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    In stock
  2. Calibration Program - GMP SOP
    Calibration Program - GMP SOP
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    Regular Price $160.00 Today $139.00
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  3. Computer system validation and maintenance checklist - GMP Checklist
    Computer system validation and maintenance checklist - GMP Checklist
    Regular Price $220.00 Today $197.00
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  4. Hosting Regulatory Inspections - GMP SOP
    Hosting Regulatory Inspections - GMP SOP
    Regular Price $220.00 Today $199.00
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  5. Refrigerated Shipment - GMP SOP
    Refrigerated Shipment - GMP SOP
    Regular Price $110.00 Today $89.00
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  6. Investigation Of Complaints - GMP SOP
    Investigation Of Complaints - GMP SOP
    Regular Price $120.00 Today $99.00
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  7. Supplier Audit Program - GMP SOP
    Supplier Audit Program - GMP SOP
    Regular Price $100.00 Today $89.00
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    In stock
  8. Batch reprocessing and reworking for API (active pharmaceutical ingredients) - GMP SOP
    Batch reprocessing and reworking for API (active pharmaceutical ingredients) - GMP SOP
    Regular Price $120.00 Today $89.00
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  9. Corrective and preventive action (CAPA) - GMP SOP
    Corrective and preventive action (CAPA) - GMP SOP
    Regular Price $120.00 Today $99.00
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  10. Handling Of OOS Results - GMP SOP
    Handling Of OOS Results - GMP SOP
    Regular Price $120.00 Today $99.00
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  11. Annual Product Review - GMP SOP
    Annual Product Review - GMP SOP
    Regular Price $120.00 Today $99.00
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  12. Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench - GMP SOP
    Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench - GMP SOP
    Regular Price $100.00 Today $89.00
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  13. HPLC Calibration - GMP SOP
    HPLC Calibration - GMP SOP
    Regular Price $180.00 Today $149.00
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  14. Operation, Calibration And Maintenance Of Electronic Analytical Single Pan Balances - GMP SOP
    Operation, Calibration And Maintenance Of Electronic Analytical Single Pan Balances - GMP SOP
    Regular Price $120.00 Today $99.00
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  15. 21-CFR 820 Quality systems GMP Checklist
    21-CFR 820 Quality systems GMP Checklist
    Regular Price $260.00 Today $219.00
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  16. 21 Part 11 Compliance Plan - GMP Validation Master Plan (VMP)
    21 Part 11 Compliance Plan - GMP Validation Master Plan (VMP)
    Regular Price $280.00 Today $219.00
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  17. PAI Protocol For Drug Products - GMP Checklist
    PAI Protocol For Drug Products - GMP Checklist
    Regular Price $240.00 Today $209.00
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  18. Contract Manufacturer Solids - Contractor Quality Questionnaire - GMP Quality Contract
    Contract Manufacturer Solids - Contractor Quality Questionnaire - GMP Quality Contract
    Regular Price $240.00 Today $197.00
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  19. Technical Quality Agreement For Contract Manufacturing (Technical Agreement, Quality Agreement)
    Technical Quality Agreement For Contract Manufacturing (Technical Agreement, Quality Agreement)
    Regular Price $470.00 Today $397.00
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  20. Stability Study Program - GMP Validation Master Plan (VMP)
    Stability Study Program - GMP Validation Master Plan (VMP)
    Regular Price $230.00 Today $189.00
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  21. Preventive Maintenance (PM) Procedure - GMP SOP
    Preventive Maintenance (PM) Procedure - GMP SOP
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    1 Review
    Regular Price $100.00 Today $89.00
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  22. Contract testing laboratory - quality questionnaire - GMP Quality Contract
    Contract testing laboratory - quality questionnaire - GMP Quality Contract
    Regular Price $240.00 Today $197.00
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  23. Testing Agreement For Medical Devices - GMP Quality Contract
    Testing Agreement For Medical Devices - GMP Quality Contract
    Regular Price $230.00 Today $189.00
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  24. API - Drug Substances - Site Master File (SMF)
    API - Drug Substances - Site Master File (SMF)
    Regular Price $280.00 Today $219.00
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  25. Drug Products - Site Master File (SMF)
    Drug Products - Site Master File (SMF)
    Regular Price $280.00 Today $219.00
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  26. General Rules for Laboratories Operating under Good Laboratory Practice (GLP)
    General Rules for Laboratories Operating under Good Laboratory Practice (GLP)
    Regular Price $160.00 Today $139.00
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  27. PAI protocol for API - GMP Checklist
    PAI protocol for API - GMP Checklist
    Regular Price $230.00 Today $198.00
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  28. Handling Of Chemicals, Reagents And Solutions In Laboratories - GMP SOP
    Handling Of Chemicals, Reagents And Solutions In Laboratories - GMP SOP
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    Regular Price $70.00 Today $49.00
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  29. Pest Control Program - GMP SOP
    Pest Control Program - GMP SOP
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    Regular Price $120.00 Today $89.00
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  30. Returned Drug Products - GMP SOP
    Returned Drug Products - GMP SOP
    Regular Price $100.00 Today $89.00
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  31. Training - GMP SOP
    Training - GMP SOP
    Regular Price $120.00 Today $99.00
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  32. Self-Inspection Program - GMP SOP
    Self-Inspection Program - GMP SOP
    Regular Price $100.00 Today $79.00
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  33. Product Recall - GMP SOP
    Product Recall - GMP SOP
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    2 Reviews
    Regular Price $140.00 Today $119.00
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  34. GMP Document Management - GMP SOP
    GMP Document Management - GMP SOP
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    1 Review
    Regular Price $100.00 Today $89.00
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  35. Creating, Reviewing, Approving And Issuing an SOP - GMP SOP
    Creating, Reviewing, Approving And Issuing an SOP - GMP SOP
    Regular Price $140.00 Today $129.00
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  36. Deviations (Failure Investigations, Non-Conformance) - GMP SOP
    Deviations (Failure Investigations, Non-Conformance) - GMP SOP
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    Regular Price $95.00 Today $79.00
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  37. Calibration of dissolution test apparatus (USP apparatus 1 and 2)
    Calibration of dissolution test apparatus (USP apparatus 1 and 2)
    Regular Price $150.00 Today $129.00
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  38. Change Control System - GMP SOP
    Change Control System - GMP SOP
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    2 Reviews
    Regular Price $120.00 Today $99.00
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  39. Supplier Certification Program - GMP SOP
    Supplier Certification Program - GMP SOP
    Regular Price $90.00 Today $79.00
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