Guidelines on packaging for pharmaceutical products -Annex 9


Guidelines on packaging for pharmaceutical products -Annex 9

Guidelines on packaging for pharmaceutical products -Annex 9

Click on the titles below for complete guidelines


1.1 General considerations 
1.2 Functions of packaging 
1.2.1 Containment 
1.2.2 Protection 
1.3 Presentation and information 
1.3.1 Labels 
1.3.2 Repacking, relabeling and dispensing 
1.3.3 Package inserts for patients (patient information leaflets) 
1.4 Compliance
1.5 Protection of patients 

2.1 Types of material 
2.1.1 Glass 
2.1.2 Plastics 
2.1.3 Metal 
2.2 Closures 
2.2.1 Rubber closures 
2.2.2 Caps or overseals 

3.1 General considerations 
3.2 Quality control 
3.2.1 Sampling 
3.2.2 Testing programme 
3.3 Inspection and audit 
3.3.1 Rules 

4.1 Packaging waste

5.1 Requirements in The international pharmacopoeia 
5.1.1 Packaging materials 
5.1.2 Requirements for dosage form containers 
5.2 Pharmacopoeial requirements for containers in Europe, Japan and the USA 
5.2.1 Glass containers 
5.2.2 Plastic containers 
5.2.3 Rubber closures 

Introductory note

This review of the various elements of the packaging of a pharmaceutical product is aimed at ensuring that medicines arrive safely in the hands of the patients for whom they are prescribed.

In the manufacture of pharmaceutical products, quality assurance is defined as “the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use” (1).

In addition, the system of quality assurance for the manufacture of pharmaceutical products should ensure that “arrangements are made for the manufacture, supply and use of the correct starting and packaging materials” (1).

Guidelines on packaging for pharmaceutical products -Annex 9

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