- Palabras clave > Good Manufacturing Practices (GMP)
- Palabras clave > inspection and audit
- Palabras clave > international pharmacopoeia - requirements
- Palabras clave > international standards
- Palabras clave > labelling
- Palabras clave > packaging requirements
- Palabras clave > quality assurance
- Palabras clave > quality control - lot testing
- Palabras clave > self inspection
- Palabras clave > storage
- Palabras clave > stockage
(2002; 38 pages)
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".
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".
Public opinion sometimes considers packaging to be superfluous. However, it must be emphasized that packaging preserves the stability and quality of medicinal products and protects them against all forms of spoilage and tampering.
All medicinal products need to be protected and "consequently need to be packaged in containers that conform to prescribed standards, particularly with respect to the exclusion of moisture and light and the prevention of leaching of extractable substances into the contents and of chemical interaction with the contents"...