Equipment used in the manufacture,
processing, packing, or holding of a drug product shall be of appropriate design,
adequate size, and suitably located to facilitate operations for its intended use
and for its cleaning and maintenance.
21 CFR Part 211, Sec 211.63
Validation should be considered as
part of the complete life cycle of a computer system. This cycle includes the stages of
planning, specification, programming, testing, commissioning, documentation, operation,
monitoring and modifying.
EU GMP, Annex 11, Computerized Systems
The manufacturer shall establish and implement an effective
pharmaceutical quality assurance system, involving the active
participation of the management and personnel of the different
departments.
COMMISSION DIRECTIVE 2003/94/EC, Article 6
It is a requirement of
GMP that manufacturers identify what validation work is needed to prove
control of the critical aspects of their particular operations. Significant
changes to the facilities, the equipment and the processes, which may affect
the quality of the product, should be validated. A risk assessment approach
should be used to determine the scope and extent of validation.
EU GMP, Annex 15, Qualification and validation