Lemetti, Inc.

Bringing Science to Business™

Independent Technology and Compliance Consultant

Validation Master Plan [DQ/IQ/OQ/PQ:

Validation can be applied to a single chamber or to an entire facility. We provide guidance starting from the start, write necessary documentation, execute the protocol and write the final report. The following provides a more amplified version of validation as it relates to equipment or facility. Master Validation Plan (MVP) for a facility is composed of the following.

Design Qualification (DQ)

Design aspects of equipment/facility is documented, checked and approved. The DQ contains descriptions and shows that the equipment/facility design agrees with the design specifications of the customer. Design aspects defined must be listed and evaluated with respect to their influence on product quality.

Design is checked to ensure that applicable codes of federal regulations are fulfilled and compliance to good manufacturing practices is documented. In the definition of the DQ, qualified personnel from various departments of the company should be involved. The involvement is important in the DQ for the identification and definition of which must be performed later phases.

DQ demanded by the customer are compared with the actual design of the equipment/facility. Written evidence of this comparison is produced. Once DQ is approved, the status of the DQ is frozen and the DQ and the specifications are now under the control of change management.

Installation Qualification (IQ)

IQ provides written evidence is supplied that all equipment in the facility are installed according to the equipment supplier(s) and purchase specifications. For complicated or large pieces of equipment, it is possible to undertake a pre-delivery check of the equipment at the supplier’s assembly facility. It is documented that the operating criteria for the equipment, as installed, are in compliance with the P&I diagrams, facility functional specifications, and process flow diagrams.

The IQ represents the status of the equipment/facility where the completeness and correctness of all required documents are confirmed. IQ refers as often as possible to engineering documents, such as P&I diagrams, functional specifications, process flow diagrams, and inventory lists to reduce documentation.

An auditor and a witness carry out the test procedures given in the approved IQ protocols. During the test procedures, the auditor will decide whether or not the test acceptance criterion is/are fulfilled. A witness certifies by signature that the test procedures are carried out by the auditor in accordance with their test specifications. Results of the test procedures become the IQ report.

Operational Qualification (OQ)

OQ provides documented evidence is given that all parts of the equipment/facility work within their specifications and process parameters are within the acceptance criteria.

Standard operating procedures (SOPs), maintenance, calibration, and cleaning should be developed during the OQ process, including maintenance and calibration schedules. Each OQ document contains a list of required SOPs for the use of a piece of equipment in the facility. Training of staff should take place and be documented. Calibrations of measuring and controlling devices are confirmed. Start-up protocols and engineering documents refer as often as possible to engineering documents, such as P&I diagrams, plant functional specifications, process flow diagrams, and inventory lists to minimize documentation; like in IQ.

The test procedures are carried out by an auditor and a witness. During test procedures, the auditor will decide whether or not the tests acceptance criteria are fulfilled. The witness certifies by signature that the test procedures are carried out by the auditor in accordance with their test specifications. The OQ protocols are filled in with all results of the test procedures and become the OQ report. The OQ reports will be approved by responsible persons.

Performance Qualification (PQ)

PQ provides documented evidence that all parts of the facility and the processes validated produce products of the specified quality under conditions of normal production. It is shown that product quality is within the specifications as long as the quality of raw materials stays within specification. The PQ includes critical variable studies, for example, by simulating conditions of upper and lower processing, processing at the operating limits of the equipment, or cir­cumstances like worst‑case conditions. It is shown that such conditions should not necessarily induce process or product failure.

PQ qualifies the entire facility with respect to production. All necessary protocols should be approved. Values of critical and non-critical process parameters recorded during PQ must be collected to evaluate the efficiency and performance of the equipment/facility.