Processes, owners fundamentals

Regulators consider the VMP to be the first fundamental commitment of the pharmaceutical organization to the validation process. In particular, the VMP must recognize that different approaches may be required to meet the differing capabilities of the various suppliers contributing to the EMS architecture. The VMP must be reviewed and approved by the project sponsor, GxP process owners, and quality assurance representative. Table 31.4 lists the typical contents of the VMP. 

Audits by INPO and the U.S. NRC aie a culmination of a high degree of self-auditing by the plant operators and the utihties themselves, often assisted by special third-party safety review boards set up to help carry out safety assessments (21). Self-auditing and self-criticism are essential to the process. These reflect the fundamental reactor safety principle that the owner-operator of the plant has the ultimate responsibiUty for plant safety. 

The company strongly supports owner responsibility on the part of the production leaderknowing reactive chemicals and their process hazards, participating in the establishment and maintenance of corporate memory, and demonstrating a fundamental understanding of reactive chemical hazards within the facility within 90 days of any new assignment. 

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