Your Account | Show all documents Standard Operating Procedure ChecklistsMaster Plans Quality Contracts Online Consultancy Consultancy Request Consultancy Process News & Trends Newsletter FDA EMEA Regulatory Links Organisations Pre-Approval-Inspection Payment Methods Company Profile Terms and Conditions Privacy Policy Contact GMP Guide Documenation Standard Operation Procedure FDA Process Validation Bookmark this site:     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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