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Search results for: 'do cgmps require three successful process validation batches before a new active_n7'

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  1. 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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  2. 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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  3. Annual Product Review - GMP SOP
    Annual Product Review - GMP SOP
    Regular Price $120.00 Today $99.00
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  4. Validation Master Plan - Drug Substance Manufacturing (API)
    Validation Master Plan - Drug Substance Manufacturing (API)
    Regular Price $200.00 Today $179.00
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  5. Drug Product Manufacturing - GMP Validation Master Plan (VMP)
    Drug Product Manufacturing - GMP Validation Master Plan (VMP)
    Regular Price $230.00 Today $199.00
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  6. Computer system validation and maintenance checklist - GMP Checklist
    Computer system validation and maintenance checklist - GMP Checklist
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  7. 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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  8. 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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  9. Drug Products - Site Master File (SMF)
    Drug Products - Site Master File (SMF)
    Regular Price $280.00 Today $219.00
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  10. Supplier Audit Program - GMP SOP
    Supplier Audit Program - GMP SOP
    Regular Price $100.00 Today $89.00
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  11. Batch reprocessing and reworking for API (active pharmaceutical ingredients) - GMP SOP
    Batch reprocessing and reworking for API (active pharmaceutical ingredients) - GMP SOP
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  12. Calibration Program - GMP SOP
    Calibration Program - GMP SOP
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  13. 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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  14. 21-CFR 820 Quality systems GMP Checklist
    21-CFR 820 Quality systems GMP Checklist
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  15. 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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  16. 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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  17. Handling Of OOS Results - GMP SOP
    Handling Of OOS Results - GMP SOP
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  18. Classification Evaluation Approval Of Cleaning Agents - GMP SOP
    Classification Evaluation Approval Of Cleaning Agents - GMP SOP
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  19. Preventive Maintenance (PM) Procedure - GMP SOP
    Preventive Maintenance (PM) Procedure - GMP SOP
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    Regular Price $100.00 Today $89.00
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  20. 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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  21. 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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  22. General Rules for Laboratories Operating under Good Laboratory Practice (GLP)
    General Rules for Laboratories Operating under Good Laboratory Practice (GLP)
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  23. Self-Inspection Program - GMP SOP
    Self-Inspection Program - GMP SOP
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  24. Change Control System - GMP SOP
    Change Control System - GMP SOP
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  25. Refrigerated Shipment - GMP SOP
    Refrigerated Shipment - GMP SOP
    Regular Price $110.00 Today $89.00
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  26. Investigation Of Complaints - GMP SOP
    Investigation Of Complaints - GMP SOP
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  27. GMP Document Management - GMP SOP
    GMP Document Management - GMP SOP
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  28. PAI protocol for API - GMP Checklist
    PAI protocol for API - GMP Checklist
    Regular Price $230.00 Today $198.00
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  29. 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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  30. Hosting Regulatory Inspections - GMP SOP
    Hosting Regulatory Inspections - GMP SOP
    Regular Price $220.00 Today $199.00
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  31. 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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  32. Pre Approval Inspection - PAI - Free GMP SOP
    Pre Approval Inspection - PAI - Free GMP SOP
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  33. 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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  34. 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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  35. Creation and use of GMP equipment logbooks - Free GMP SOP
    Creation and use of GMP equipment logbooks - Free GMP SOP
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  36. Supplier Certification Program - GMP SOP
    Supplier Certification Program - GMP SOP
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  37. Refrigerated Shipment - Qualification Master Plan (VMP)
    Refrigerated Shipment - Qualification Master Plan (VMP)
    Regular Price $210.00 Today $199.00
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  38. NDA Field Alert Version 03 - GMP SOP
    NDA Field Alert Version 03 - GMP SOP
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    Regular Price $120.00 Today $99.00
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  39. 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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  40. Training - GMP SOP
    Training - GMP SOP
    Regular Price $120.00 Today $99.00
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  41. Product Recall - GMP SOP
    Product Recall - GMP SOP
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    Regular Price $140.00 Today $119.00
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  42. HPLC Calibration - GMP SOP
    HPLC Calibration - GMP SOP
    Regular Price $180.00 Today $149.00
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  43. Returned Drug Products - GMP SOP
    Returned Drug Products - GMP SOP
    Regular Price $100.00 Today $89.00
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