as of 2019 - 08 - 15
21 Active Pharmaceutical Ingredients
21.A Introduction
Summary
21.A.1 Differences between active substance manufacturing and medicinal product manufacturing
21.A.2 Definitions
21.A.2.1 Active substances
21.A.2.2 Starting materials
21.B Regulatory principles
Summary
21.B.1 General GMP regulatory works
21.B.1.1 Global
21.B.1.2 USA
21.B.1.3 Europe
21.B.2 Regulatory works for biotechnological active substances
21.B.2.1 Global
21.B.2.2 USA
21.B.2.3 Europe
21.B.3 Compulsory registration
21.B.4 Required authorisations
21.B.4.1 Manufacturing authorisation
21.B.4.2 Import authorisation
21.B.5 Import
21.B.5.1 Written Confirmation
21.B.6 Release
21.B.7 Official supervision
21.C Marketing authorisation documentation for active substances
Summary
21.C.1 Information on marketing authorisation for active substances
21.C.2 What is an EDMF/ASMF?
21.C.3 What is a CEP?
21.C.4 Additional details on EDMF/ASMF and/or CEP
21.C.4.1 GMP compliance of production
21.C.4.2 Revoking or suspending a CEP
21.D GMP Certificates
Summary
21.D.1 Certificates as documents of proof (ISO, GMP, CEP)
21.D.2 GMP Certificates of the EU, PIC/S and WHO
21.D.2.1 What is the significance of an EU-GMP certificate?
21.D.2.2 What is the significance of GMP certificates from PIC/S and the WHO?
21.D.3 GMP certificates of other national health authorities from third countries (not EU, PIC/S or WHO)
21.E Auditing active substance manufacturers
Summary
21.E.1 Regulatory requirements and professional prerequisites
21.E.2 Active substances from Europe and/or third countries (such as China or India)
21.E.3 Audits
21.E.3.1 Definitions
21.E.3.2 Preparing for an audit
21.E.3.3 Conducting the audit
21.E.3.4 Audit findings
21.E.4 Third Party Audits
21.E.4.1 Mandatory auditing of active substances
21.E.4.2 Requirements for third-party audits
21.E.5 Audit Checklists
21.F Chemical active substances
Summary
21.F.1 What are chemical active substances?
21.F.2 Definition of terms
21.F.3 Scope of GMP regulations
21.F.4 Basic GMP requirements
21.F.5 Special Risks
21.F.5.1 Impurities: Genotoxic or potentially genotoxic substances
21.F.5.2 Impurities: Residual solvents
21.F.5.3 Impurities: Heavy metals or residues from metal catalysts/metal reactants
21.F.5.4 Other impurities
21.F.6 Typical GMP deficiencies in chemical active substance manufacturing
21.F.6.1 Quality management
21.F.6.2 Buildings and facilities
21.F.6.3 Process equipment
21.F.6.4 Documentation and records
21.F.6.5 Materials management
21.F.6.6 Packaging and identification labelling of APIs and intermediates
21.F.6.7 Laboratory controls
21.F.6.8 Validation
21.G Biotechnological active substances
Summary
21.G.1 What are biotechnological active substances?
21.G.2 Types of biotechnological active substances
21.G.3 Definition of terms
21.G.4 Scope of GMP regulations
21.G.5 Special risks
21.G.6 Basic GMP regulations
21.G.6.1 Personnel
21.G.6.2 Premises and equipment
21.G.6.3 Documentation
21.G.6.4 Production and control strategy
21.G.6.5 Starting and raw materials
21.G.6.6 Seed culture and cell bank system
21.G.6.7 Working principles and production
21.G.6.8 Quality Control
21.G.6.9 Animals
21.G.7 Specific GMP regulations
21.G.7.1 Allergenic products
21.G.7.2 Immunosera of animal origin
21.G.7.3 Vaccines
21.G.7.4 Recombinant products
21.G.7.5 Monoclonal antibodies
21.G.7.6 Transgenic plant products
21.G.7.7 Gene therapy medicinal products
21.G.7.8 Somatic and xenogeneic cell therapy medicinal products and tissue engineered products
21.H References
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