Cleanroom Validation


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.