Validation Guideline for Facility and Utility

This validation guideline for facility and utility aims to provide a clear statement of the scope, validation approach, and testing required for validating the facilities and utilities that are directly or indirectly involved in the manufacturing processes.

This validation guideline will apply to all GMP critical facilities and utilities.

Responsibilities for validation

It is the responsibility of the validation committee to review and approve the master validation plan, thereby approving the general approach and methods to be employed in the validation of the manufacturing facilities and utilities used throughout the manufacturing facility.

Technical Services

– The Technical Services department is responsible for establishing and maintaining facility/utility validation programs and developing and approving all guidelines, plans, protocols, and reports.

– Technical Services is responsible for verifying that all facility/utility validation programs comply with this guideline and current GMP practices.

Engineering

– Engineering is responsible for ensuring that validated utilities support all major GMP manufacturing equipment as applicable and that facilities are qualified.

Quality Assurance

– Quality Assurance is responsible for ensuring that the GMP aspects of the facility/utility validation program comply with relevant procedures and that critical parameters and report conclusions are supported.

Rationale for validation of facility and utility

Installation Qualification and Operational Qualification exercises assure, through appropriate performance tests and related documentation and records, that facilities and utilities have been commissioned correctly and that they will be reliable and within prescribed or specified operating limits.

The validation approach will be based on a risk assessment following the SOP for Quality Risk Management and the impact assessment outlined in the SOP Validation Impact Assessment Procedure.

Qualification will be performed if the utility directly affects product quality as described in this section. Qualification may not be required if the utility does not directly affect product quality.

Quality Assurance must approve the justification for not qualifying the utility. Facility Qualification will be performed in GMP areas only.

Validation Project Plan

A validation project plan (VPP) should be written for large-scale projects. VPPs represent dynamic, project-specific master validation plans, often accompanied by several appendices that change as the project progresses.

Design Qualification

The first element of the validation of the new facilities and utilities is Design Qualification (DQ).

The DQ documents that the design of facilities and utilities meets GMP, process user, and safety requirements and is suitable for its intended use.

The DQ process can be incorporated into the IQ or validation report.

Installation Qualification

Installation Qualification (IQ) provides documented evidence that the facilities and utilities have been installed according to their design specifications, user requirements, and manufacturer recommendations.

Furthermore, IQ ensures that a record of the principal features of the facilities and utilities, as installed, is available and supported by sufficient documentation to enable satisfactory operation, maintenance, and change control to be implemented.

Installation Qualification (IQ) should be performed on new or modified facilities and utilities.

IQ should include an appropriate, but not limited to the following:

– Installation of piping, services, and instrumentation checked to current engineering drawings and specifications;

– Collection and collation of supplier operating and working instructions and maintenance requirements;

– Calibration requirements;

– Verification of materials of construction;

– Cleaning and passivation results;

– Pressure testing/weld checks/pipe slope isometrics;

– Safety requirements;

– Training.