Sterile Manufacturing

Chapter 1 Introduction Chapter 2 Data Integrity Compliance Chapter 3 Risk-Based Life Cycle Management Chapter 4 FMEA Manufacturing Procedure Chapter 5 Classified Areas Chapter 6 Sterile Manufacturing Facilities Chapter 7 Personnel behaviors, Personal Protective Equipment (PPE), and Process Flow Chapter 8 Quality Approach for Systems Validation Chapter 9 Dedicated Facilities Chapter 10 Contamination Chapter 11 Containment Chapter 12 Suppliers Chapter 13 Single-Use Technologies (SUT) Chapter 14 Master Qualification Plan Chapter 15 Water For Injection (WFI) Chapter 16 Integrated Facility Design Chapter 17 Sterile Techniques Chapter 18 Compliance Chapter 19 Controls Chapter 20 Barriers and Isolators Chapter 21 Quality Risk Management Chapter 22 Equipment Qualification (EQ) Chapter 23 Process Validation Chapter 24 Change Control Chapter 25 Analytical Testing of Raw Material Quality Chapter 26 Product Life Cycle Chapter 27 Quality by Design (QbD) Chapter 28 Sterilization Chapter 29 Cleaning Validation Chapter 30 Lyophilization

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• Farmácia / receituário
• Estudo médico e guias de revisão e material de referência
• Química industrial e tecnologias de fabrico

Sterile Manufacturing;Sip;Medical device space;URS;GMP inspectors;Doe;Medicinal products;Aseptic Core;Operational requirements;FMEAs;CPPs;RABS;Ich;Sterile Filter;CFR;Fat;Aseptic Manufacturing;Capa;Moisture Content;Sterility Assurance Level;PFS;WFI System;Electronic Batch Records;Aseptic Processing;Quality Risk Management;LAL;MES;Computer Systems Validation;Process Performance Qualification