Documenting Infrastructure Requirements

The organization must document the requirements for the infrastructure needed to ensure the product can be consistently manufactured to its requirements, prevent mix-ups and ensure appropriate handling of the product. These infrastructure requirements include the building, workspace and utilities; process equipment; and supporting services such as transportation and information systems.

Validation Master Plan (VMP)

Most of the infrastructure requirements for ISO 13485 will generally be documented in a Master Validation Plan (MVP), also sometimes referred to as a Validation Master Plan (VMP). We’ll use VMP since that aligns with the Good Automated Manufacturing Practices (GAMP) documents published by the ISPE.