VALIDATION & DOCUMENTATION SERVICES
It includes an array of documentation, tools and expertise required to successfully qualify and validate a new or existing Equipment within accepted IQ/OQ/PQ/DQ protocols. This include installation, operation, design and performance qualification (IQ/OQ/PQ/DQ) to help you comply with the current & International Standards
Installation Qualification (IQ) provides documentary evidence that the equipment has been built and installed to specification, and that all supporting services (i.e., utilities such as electricity, water, Compressed Air, Etc) are available and connected properly. The IQ process methodically documents all aspects of the installation, the machine components, and any testing equipment used to provide a complete, closed-loop assessment. In addition, IQ includes traceable calibration Certificates of the unit’s critical components.
- IQ is typically carried out concurrently with or after the equipment installation at the user’s facility. The IQ is performed by following a specific IQ protocol tailored for each piece of equipment.
- IQ can be performed by a third party using the Consolidated IQ Template, or by an authorized Hospharma’s representative following the IQ Template.
Operational Qualification (OQ) provides documented evidence that the Equipment operates in accordance with design specifications. The OQ validation examines the equipment ability to run the working process correctly and to respond appropriately to error conditions, assuring that the equipment performs as intended.
- Alarm conditions and expected results are verified.
- OQ can be performed by a third party using the Hospharma’s Template, or by an authorized Hospharma’s representative following the OQ Template.
Performance Qualification (PQ) documents the equipment’s ability to achieve the desired outcome when operated in accordance with predefined operating procedures.
- The Equipment is tested with actual production loads.
- Prior to PQ all required methods and Standard Operating.
- Procedures must be finalized and operator training completed.
Design Qualification (DQ) documents the specification required for equipment like capabilities, Features, Installation Description, Etc. It describes the features required for the equipment as well as outlines the decision process to select the equipment.
- It is performed prior to purchase of the equipment.
- It indicates Equipment description, Specification and reason for selection of this model.