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as of 2019 - 01 - 24
13 Packaging
13.A Packaging materials
Summary:
13.A.1 General requirements for packaging materials
13.A.2 Primary packaging materials
13.A.2.1 Tasks and functions
13.A.2.2 Selection of suitable primary packaging materials
13.A.2.3 Blister packs
13.A.2.4 Plastic containers
13.A.2.5 Injection/infusion containers and accessories
13.A.2.6 Tubes made of aluminium, plastic and composite materials
13.A.2.7 Glass and plastic bottles and accessories for liquid products
13.A.3 Secondary packaging materials
13.A.3.1 Tasks and functions
13.A.3.2 Labels/adhesive labels
13.A.3.3 Patient information leaflets/package inserts
13.A.3.4 Folding cartons
13.A.3.5 Corrugated cardboard folding boxes
13.A.4 Labelling requirements
13.A.5 Standardisation of packaging materials
13.A.6 Protection against counterfeit medicinal products
13.A.7 Specifications for packaging materials
13.A.8 Packaging material testing
13.A.8.1 Packaging material suppliers
13.A.8.2 Sampling, scope of sampling and AQL values
13.A.8.3 PPM evaluation system
13.A.8.4 General procedure for testing packaging materials
13.A.8.5 Specific testing of primary packaging materials
13.A.8.6 Specific testing of secondary packaging materials
13.A.9 Storage and labelling of packaging materials
13.B Packaging process
Summary
13.B.1 Packaging medicinal products
13.B.1.1 Packaging in blisters
13.B.1.2 Packaging in PE or glass bottles
13.B.1.3 Other types of packaging (e.g. tubes)
13.B.1.4 The packaging process
13.B.2 Provision of packaging materials
13.B.3 Line clearance
13.B.4 Line setup and line release
13.B.5 Production and in-process controls
13.B.5.1 Control functions
13.B.5.2 Functional tests
13.B.5.3 Checking (partially) packaged goods
13.B.5.4 Handling samples and rejects
13.B.5.5 Organisation of in-process controls
13.B.6 Labelling
13.B.6.1 Variable data
13.B.6.2 Printing
13.B.6.3 Labels
13.B.6.4 Vignettes
13.B.7 Reconciliation
13.B.8 Completion of a packaging process
13.B.9 Measures to protect against counterfeit medicinal products
13.C Qualification of a servo-controlled blister packaging line
Summary
13.C.1 Introduction
13.C.2 Qualification in accordance with GAMP 5
13.C.2.1 Basic risk assessment
13.C.2.2 Requirement specification
13.C.2.3 Supplier audit
13.C.2.4 Functional specification
13.C.2.5 Configuration specification
13.C.2.6 Functional risk assessment
13.C.2.7 Configuration test
13.C.2.8 Functional test
13.C.2.9 Requirements test (user requirements)
13.C.3 Example of a functional risk assessment
13.C.3.1 Blister machine
13.C.3.2 Cartoning machine
13.C.3.3 Checkweigher
13.C.3.4 Control systems (blister and cartoning machine)
13.C.3.5 Supply media
13.C.3.6 Ambient conditions
13.C.4 Example of an FMEA risk analysis (extract)
13.C.5 Example of an IQ qualification plan (extract)
13.C.5.1 IQ-02: Checking the validity of the sealing heater calibration certificate
13.C.6 Example of an OQ qualification plan (extract)
13.C.6.1 OQ-03: Functional test: Insufficient temperature of the sealing heater
13.D Blow-fill-seal technology (BFS technology)
Summary
13.D.1 Principles of BFS technology
13.D.1.1 Development of BFS technology
13.D.1.2 Basic system types
13.D.1.3 How BFS technology works – cycle machines
13.D.1.4 How BFS technology works – rotary machines
13.D.2 Application of BFS technology
13.D.2.1 Fields of application
13.D.2.2 Possible products for BFS technology
13.D.2.3 Container forms for BFS technology
13.D.2.4 Materials for BFS technology
13.D.2.5 Limitations of BFS technology
13.D.3 Qualification and validation
13.D.3.1 System qualification
13.D.3.2 Process validation
13.D.3.3 Environmental validation
13.D.4 Operation of a BFS system
13.D.4.1 Required media
13.D.4.2 Ambient conditions
13.D.4.3 Operator training and clothing
13.D.4.4 Carrying out inspections during operation
13.D.4.5 Cleaning a BFS system
13.D.4.6 Sterilising a BFS system
13.E References
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