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GMP Guide
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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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