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Available Documents
 

  Standard Operation Procedures
Creation and use of GMP equipment logbooks 0.– EUR *
(appr. 0.- USD)
 
HPLC Calibration 155.– EUR *
(appr. 200.- USD)
 
Operation, calibration and maintenance of electronic analytical single pan balances 95.– EUR *
(appr. 123.- USD)
 
Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench 79.– EUR *
(appr. 102.- USD)
 
Hosting Regulatory Inspections 179.– EUR *
(appr. 231.- USD)
 
Preventive maintenance (PM) procedure 79.– EUR *
(appr. 102.- USD)
 
Annual product review 85.– EUR *
(appr. 110.- USD)
 
Supplier certification program 79.– EUR *
(appr. 102.- USD)
 
Change control system 79.– EUR *
(appr. 102.- USD)
 
Calibration of dissolution test apparatus (USP apparatus 1 and 2) 119.– EUR *
(appr. 154.- USD)
 
Deviations (failure investigations, non-conformance) 79.– EUR *
(appr. 102.- USD)
 
Creating, reviewing, approving and issuing an SOP 89.– EUR *
(appr. 115.- USD)
 
Calibration program 85.– EUR *
(appr. 110.- USD)
 
GMP document management 79.– EUR *
(appr. 102.- USD)
 
Corrective and preventive action (CAPA) 95.– EUR *
(appr. 123.- USD)
 
NDA field alert 95.– EUR *
(appr. 123.- USD)
 
Supplier audit program 79.– EUR *
(appr. 102.- USD)
 
Product Recall 89.– EUR *
(appr. 115.- USD)
 
Self-inspection program 79.– EUR *
(appr. 102.- USD)
 
Training 89.– EUR *
(appr. 115.- USD)
 
Batch reprocessing and reworking for API (active pharmaceutical ingredients) 89.– EUR *
(appr. 115.- USD)
 
Investigation of complaints 89.– EUR *
(appr. 115.- USD)
 
Handling of OOS results 89.– EUR *
(appr. 115.- USD)
 
Returned drug products 79.– EUR *
(appr. 102.- USD)
 
Classification evaluation approval of cleaning agents 69.– EUR *
(appr. 89.- USD)
 
SOP for refrigerated shipment 75.– EUR *
(appr. 97.- USD)
 
Pest control program 49.– EUR *
(appr. 63.- USD)
 
Handling of chemicals, reagents and solutions in laboratories 45.– EUR *
(appr. 58.- USD)
 
* additional 19% tax for customers from germany / no shipping costs will be charged
  Checklists
Test - DO NOT ORDER 1.– EUR *
(appr. 1.- USD)
 
PAI protocol for API 189.– EUR *
(appr. 244.- USD)
 
PAI protocol for drug products 199.– EUR *
(appr. 257.- USD)
 
21-CFR 820 Quality systems checklist 210.– EUR *
(appr. 271.- USD)
 
Computer system validation and maintenance checklist 185.– EUR *
(appr. 239.- USD)
 
* additional 19% tax for customers from germany / no shipping costs will be charged
  Master Plans
Stability Study Program / Plan 189.– EUR *
(appr. 244.- USD)
 
General Rules for Laboratories Operating under Good Laboratory Practice (GLP) 130.– EUR *
(appr. 168.- USD)
 
Site master file (SMF) for drug products 230.– EUR *
(appr. 297.- USD)
 
Site master file (SMF) for API - drug substances 230.– EUR *
(appr. 297.- USD)
 
Dossier-Maître Site (Site Master File) - Version Français 230.– EUR *
(appr. 297.- USD)
 
21 Part 11 compliance plan 230.– EUR *
(appr. 297.- USD)
 
Validation master plan for solid and semi-solid manufacturers 195.– EUR *
(appr. 252.- USD)
 
Validation master plan drug substance manufacturing (API) 160.– EUR *
(appr. 206.- USD)
 
Qualification master plan for refrigerated shipment 175.– EUR *
(appr. 226.- USD)
 
* additional 19% tax for customers from germany / no shipping costs will be charged
  Quality Contracts
Contract manufacturer solids - contractor quality questionnaire 199.– EUR *
(appr. 257.- USD)
 
Contract testing laboratory - quality questionnaire 199.– EUR *
(appr. 257.- USD)
 
* additional 19% tax for customers from germany / no shipping costs will be charged

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