Documentation are to define the manufacturers system of information & control to minimize the risk of misinterpretation & errors inherent in oral or casually written communication, to provide unambiguous procedures to be followed to provide confirmation of performance, to allow calculations to be checked & to allow tracing of batch history.

• Documentation is an integral part of good manufacturing practices.
• It consequently strengthens the quality and its consistency of all goods and services as those responsible for the specific operations have clear unambiguous instructions to follow including active drug substances is legally mandatory.
• Documentation within pharmaceutical industry is an essential part of both the Quality assurance and Quality control system.
• Documentation describes the specifications for all materials, methods of manufacturing and control.
• The Pharmaceutical industries are in a highly regulated environment hence it requires effective document management processes