Cleanroom Documentation
The Cleanroom Documentation Package (CDP) is a critical set of documents that ensures cleanrooms meet industry standards and regulations for use in controlled environments, such as pharmaceutical or biotech manufacturing. The Cleanroom Qualification and Validation (CQV) process is a structured approach to validating that the cleanroom operates as required and can maintain the necessary cleanliness levels, environmental conditions, and operational parameters. Below is a list of CQV documentation required for cleanrooms, along with a brief description of each document: Cleanrooms | Cleanroom Consulting | Biotech Cleanrooms 1. Cleanroom CQV-Construction Plan Purpose: The Construction Plan outlines the scope, timeline, resources, and methodologies for building the cleanroom facility, ensuring the project aligns with operational needs and regulatory requirements. Contents: Project scope and objectives Construction schedule and milestones Resource planning...