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Shopping Cart
 
  21-CFR 820 Quality systems checklist 210.00  EUR * [delete]  
  (appr. 271.- USD)  
  Deviations (failure investigations, non-conformance) 79.00  EUR * [delete]  
  (appr. 102.- USD)  
  Corrective and preventive action (CAPA) 95.00  EUR * [delete]  
  (appr. 123.- USD)  
  NDA field alert 95.00  EUR * [delete]  
  (appr. 123.- USD)  
  Calibration program 85.00  EUR * [delete]  
  (appr. 110.- USD)  
  Operation, calibration and maintenance of electronic analytical single pan balances 95.00  EUR * [delete]  
  (appr. 123.- USD)  
  Self-inspection program 79.00  EUR * [delete]  
  (appr. 102.- USD)  
  Handling of OOS results 89.00  EUR * [delete]  
  (appr. 115.- USD)  
  GMP document management 79.00  EUR * [delete]  
  (appr. 102.- USD)  
  Creating, reviewing, approving and issuing an SOP 89.00  EUR * [delete]  
  (appr. 115.- USD)  
  Calibration of dissolution test apparatus (USP apparatus 1 and 2) 119.00  EUR * [delete]  
  (appr. 154.- USD)  
  Investigation of complaints 89.00  EUR * [delete]  
  (appr. 115.- USD)  
  Change control system 79.00  EUR * [delete]  
  (appr. 102.- USD)  
  Preventive maintenance (PM) procedure 79.00  EUR * [delete]  
  (appr. 102.- USD)  
  Annual product review 85.00  EUR * [delete]  
  (appr. 110.- USD)  
  Supplier certification program 79.00  EUR * [delete]  
  (appr. 102.- USD)  
  Technical quality agreement for contract manufacturing (technical agreement, quality agreement) 385.00  EUR * [delete]  
  (appr. 497.- USD)  
  Contract testing laboratory - quality questionnaire 199.00  EUR * [delete]  
  (appr. 257.- USD)  
  Contract manufacturer solids - contractor quality questionnaire 199.00  EUR * [delete]  
  (appr. 257.- USD)  
  General Rules for Laboratories Operating under Good Laboratory Practice (GLP) 130.00  EUR * [delete]  
  (appr. 168.- USD)  
  Qualification master plan for refrigerated shipment 175.00  EUR * [delete]  
  (appr. 226.- USD)  
  Stability Study Program / Plan 189.00  EUR * [delete]  
  (appr. 244.- USD)  
  Validation master plan for solid and semi-solid manufacturers 195.00  EUR * [delete]  
  (appr. 252.- USD)  
  Dossier-Maître Site (Site Master File) - Version Français 230.00  EUR * [delete]  
  (appr. 297.- USD)  
  Site master file (SMF) for drug products 230.00  EUR * [delete]  
  (appr. 297.- USD)  
  Validation master plan drug substance manufacturing (API) 160.00  EUR * [delete]  
  (appr. 206.- USD)  
  21 Part 11 compliance plan 230.00  EUR * [delete]  
  (appr. 297.- USD)  
  TOTAL  3847.00  EUR *    
    (appr. 4,963.- USD)  
* additional 19% tax for customers from germany / no shipping costs will be charged



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