Good Information Technology Practices

The Good Automated Manufacturing Practices (GAMP) Forum has developed guidelines for computer validation [5] and a draft guidance on quality assurance of information technology (IT) infrastructure [6]. 

There are no records to document that the Information Technology (IT) service provider staff persormel have received training that includes current good manufacturing practice regulations and written procedures referred by the regulations. [FDA 483, 2000]... 

Even if software meets all of the user requirements and functional and technical specification, it might still be subject to several business implications. Those cases include any business impact outside the immediate application area, such as information technology (IT) requirements, security issues, increased need for maintenance, and pricing. The V-Model includes a final business acceptance phase that is intended to cover all potential implications as best as possible. For this and other numerous reasons, it is a good practice to involve the end-user community, IT personnel, and management during all phases of a development project. 

In this chapter, an example company policy for quality assurance of IT (information technology) systems is presented. It provides an overview of Good IT Practices that would normally be expected from internal IT project and support groups within a pharmaceutical manufacturing company. These IT practices are equally applicable to supplier organizations providing project and support services. 

Some of the recognised potentials for improvement of PDF in individual production were found as good practices in successful companies. The other improvement options are conclusions from information flow analyses and assessment of emerging information technologies and methodologies. The improvement potentials presented bellow in a comprehensive form is a desired situation for individual production. Each company needs to analyse its PDF individually and set the importance and optimal implementation way of suggested improvements. 

Like many organizations today, the USP has a mission statement and this was stated in the 27th edition the objective of a pharmacopoeia is to provide and disseminate authoritative standards for medicines, other healthcare technologies and related practices to maintain and improve public health, and to provide information for practitioners and patients. In addition, the compendial activities of the USP are also designed to support the availability of safe and good quality medicines for consumers everywhere. In parenthesis, the term quality is not defined here because it is intuitively understood by everyone. One working definition holds that a quality item is one suitable for a stated purpose, but this is somewhat unsatisfactory and a better definition is required. 

---