An Introduction to the Reference Texts and Standards for the Qualification of Clean Rooms

✍ Scribed by C. Chemtob

• Publisher: John Wiley and Sons
• Year: 1997
• Tongue: English
• Weight: 124 KB
• Volume: 2
• Category: Article
• ISSN: 1087-8378
• DOI: 10.1002/(sici)1099-1786(199703)2:1<31::aid-qaj23>3.0.co;2-p

✦ Synopsis

An Introduction to the Reference Texts and Standards for the Qualification of Clean Rooms

Sterile products must be manufactured in areas where the environment is controlled (so-called Clean Rooms). The GMP regulations of the EU, the WHO and the FDA specify the types of clean areas required depending on the operations carried out. According to these GMP principles, the manufacturers of sterile medicinal products should comply with the requirements for clean areas, but the test methods are rarely clearly specified. Since operational qualification should provide documented evidence of the facility's correct operation (compliance with defined standards), a number of normative texts concerning the qualification of Clean Rooms may usefully supplement the more general regulatory texts. This article reviews the regulatory and normative texts applied to the qualification of Clean Rooms and highlights some of the tests which may be performed to qualify premises for the manufacture of sterile products and some acceptance criteria which should be met.