| Your Account | 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 FDA Standard Operation Procedure Available Documents     Checklists   21-CFR 820 Quality systems checklist 210.– EUR (appr. 315.- USD)     PAI protocol for drug products 199.– EUR (appr. 299.- USD)     PAI protocol for API 189.– EUR (appr. 284.- USD)     Computer system validation and maintenance checklist 185.– EUR (appr. 278.- USD)     Standard Operation Procedures   Operation, calibration and maintenance of electronic analytical single pan balances 95.– EUR (appr. 143.- USD)     Aseptic Technique Guideline for Manual Operation in a Biological Safety Cabinet, under Laminar Flow Hood or in a Clean Bench 79.– EUR (appr. 119.- USD)     Hosting Regulatory Inspections 179.– EUR (appr. 269.- USD)     Preventive maintenance (PM) procedure 79.– EUR (appr. 119.- USD)     Calibration of dissolution test apparatus (USP apparatus 1 and 2) 119.– EUR (appr. 179.- USD)     Calibration program 85.– EUR (appr. 128.- USD)     Classification evaluation approval of cleaning agents 69.– EUR (appr. 104.- USD)     Corrective and preventive action (CAPA) 95.– EUR (appr. 143.- USD)     NDA field alert 95.– EUR (appr. 143.- USD)     SOP for refrigerated shipment 75.– EUR (appr. 113.- USD)     Product Recall 89.– EUR (appr. 134.- USD)     Training 89.– EUR (appr. 134.- USD)     Returned drug products 79.– EUR (appr. 119.- USD)     Pest control program 49.– EUR (appr. 74.- USD)     Self-inspection program 79.– EUR (appr. 119.- USD)     GMP document management 79.– EUR (appr. 119.- USD)     Creating, reviewing, approving and issuing an SOP 89.– EUR (appr. 134.- USD)     Handling of chemicals, reagents and solutions in laboratories 45.– EUR (appr. 68.- USD)     Batch reprocessing and reworking for API (active pharmaceutical ingredients) 89.– EUR (appr. 134.- USD)     Annual product review 85.– EUR (appr. 128.- USD)     Supplier certification program 79.– EUR (appr. 119.- USD)     Supplier audit program 79.– EUR (appr. 119.- USD)     Creation and use of GMP equipment logbooks 0.– EUR (appr. 0.- USD)     Change control system 79.– EUR (appr. 119.- USD)     Deviations (failure investigations, non-conformance) 79.– EUR (appr. 119.- USD)     Handling of OOS results 89.– EUR (appr. 134.- USD)     Investigation of complaints 89.– EUR (appr. 134.- USD)     Master Plans   Stability Study Program / Plan 189.– EUR (appr. 284.- USD)     General Rules for Laboratories Operating under Good Laboratory Practice (GLP) 130.– EUR (appr. 195.- USD)     Qualification master plan for refrigerated shipment 175.– EUR (appr. 263.- USD)     Dossier-Maître Site (Site Master File) - Version Français 230.– EUR (appr. 345.- USD)     21 Part 11 compliance plan 230.– EUR (appr. 345.- USD)     Site master file (SMF) for API - drug substances 230.– EUR (appr. 345.- USD)     Site master file (SMF) for drug products 230.– EUR (appr. 345.- USD)     Validation master plan drug substance manufacturing (API) 160.– EUR (appr. 240.- USD)     Validation master plan for solid and semi-solid manufacturers 195.– EUR (appr. 293.- USD)     Quality Contracts   Technical quality agreement for contract manufacturing (technical agreement, quality agreement) 385.– EUR (appr. 578.- USD)     Contract testing laboratory - quality questionnaire 199.– EUR (appr. 299.- USD)     Contract manufacturer solids - contractor quality questionnaire 199.– EUR (appr. 299.- USD)
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