Cleanroom Validation

Qualification

The Installation / Operational / Performance Qualification (IQ / OQ / PQ) of equipment, systems, facilities, and processes for pharmaceutical sterile, oral solid dosage, finished and bulk manufacturing operations are an essential part of the validation process.

Equipment must be installed operated, and maintained within design specifications, while processes must be shown to be reliable, all of which assure the consistent quality and integrity of a product.

The Validation Process starts with the initial Basis of Design Document that outlines the scope and boundaries of the project. For this, we can provide templates and Reference Specifications and Standard Operating Procedures (SOP) for the installation of the various systems and components.

Category: Cleanroom Design Decisions

Description

The Installation Qualification is the proving we have installed what we initially intended to, or have a detailed log of the changes and rationale for the change.

The Operational Qualification is proving that the design can consistently function in day to day use.

The Performance Qualification is how we handle the changes in operational status, which can happen with any system, and prove acceptance to start production.

This ends the construction validation process and turns over the system to the operations group.

At ESC we can assist you in understanding this process and can provide as much assistance as is required to ensure completion of the process.