According to the FDA, “the term qualification refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly. These activities necessarily precede manufacturing products at the commercial scale.”
Qualification can be further broken down into three phases: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), or IQ OQ PQ.
IQ OQ PQ is most commonly used in heavily regulated industries and in cases where product quality can affect consumer safety, including pharmaceuticals, medical devices, food, aerospace, and labs involved in R&D or testing inthese areas (note that several of these are FDA-regulated). These are areas where current Good Manufacturing Practices (cGMP) are generally applied, and many of the concepts in IQ OQ PQ will be familiar to those with a knowledge of cGMP.
When done correctly, the three phases of qualification are meticulous and time-consuming. However, they are critical to ensuring repeatable processes and stable product quality, and are important components of an overall validation plan. In addition, they provide rigorous guidelines to bring equipment online systematically and in a compliant manner.
In this article, we provide an overview of how organizations can successfully navigate IQ OQ PQ, and share examples of how they are used as part of a larger overall plan to maintain a robust QA system.
What Does IQ OQ PQ Mean for My Business?
Validation, and the qualification steps involved, are covered by various parts of 21 CFR 211 (pharmaceuticals) and 21 CFR 820 (medical devices), and are enforced by the FDA. In this context, “validation” refers to the use of objective evidence to confirm that a process, and the equipment used in the process, will consistently meet its intended specifications. It is used in cases where verification (confirmation by direct examination) is not feasible.
As an example, consider the startup of a new reactor that is part of a pharmaceutical manufacturing line:
- Before purchase, the specifications of the reactor (e.g., operating temperature, capacity of pumps and motors, materials of construction) would have been determined as part of the overall process design, and possibly as an additional step of design qualification (DQ). In installation qualification (IQ), it is confirmed and recorded that the correct reactor was delivered from the supplier, and was installed and configured according to the supplier’s recommended procedure.
- Next, before bringing the reactor online, operational qualification (OQ) is performed. Operational tests would be performed to verify the reactor can run within its specified limits when under a load simulating process conditions. A second aspect of OQ is setting process boundaries for statistical process control of the equipment later on. For example, the operating temperature window needed to generate the desired product from the reactor would be determined in OQ.
- Finally, in performance qualification (PQ) the reactor is integrated into the full manufacturing line under simulated process conditions. Here, test processes would be run with the reactor operating at the extremes of its established process window (capacity, temperatures, pressures), to test how this affects the final product. This allows the verification of the overall process, and for the process windows that were set in OQ to be further refined.
IQ OQ PQ can be thought of as a set of procedures, but a critical output of all three is a document that provides evidence that qualification standards have been met. As with any procedure done as part of cGMP, complete and accurate record-keeping is essential. Recall the ALCOA standard for data collection: attributable, legible, contemporaneous, original, and accurate.
It is recommended that the team involved in validation, including IQ OQ PQ, should be cross-functional, with a diversity of expertise. Various parts of 21 CFR also state that, “Each manufacturer shall ensure that validated processes are performed by qualified individual(s)”, and that personnel and consultants involved in all aspects of cGMP are required to have the proper “education, training, and experience, or any combination thereof”. Often, the range and depth of required expertise isn’t available in-house, and external consulting is required.
In IQ and OQ, either a single piece of equipment, or entire integrated systems can be qualified. An example of an integrated system is equipment designed to apply antimicrobials to food, which might be made up of individual parts like feed tanks, sprayers, a conveyor system, pumps, motors, and measurement systems.
In some cases, IQ and OQ are grouped together into an “equipment qualification”, and in others PQ is considered part of process validation. Here, we will treat each of the three protocols separately.
Installation Qualification (IQ) for Your Equipment
The main goals of IQ are to verify that:
- The specifications of the delivered equipment match those set by the process design
- The equipment has been properly handled, delivered, and installed
Two sources of information that should be extensively consulted are the equipment manufacturer’s documentation for installation, and the specifications set by the process design.
Specifically, before installation has taken place, issues that should be checked include:
- Confirming that the correct equipment was delivered by using, for example, a purchase order and/or packing list.
- If a nameplate is attached to the equipment, verifying the supplier(s) part number and any configurations given on the nameplate (commonly listed configurations include electrical power requirements and equipment capacity).
- Checking parts for damage.
- When multiple configurations exist, making sure that the correct configuration was selected.
- Taking measurements to confirm that any measurable aspects of the equipment are within tolerance. For example, the dimensions of any parts, of the surface finish.
- Where needed, verifying the materials of construction (MOCs). This is especially important for materials that will be coming directly in contact with the in-process material or final product (so-called “wetted” parts). MOC can be verified through certificates from the manufacturer, certification by a third party, or by direct analysis.
- Confirming that the listed process ranges of the equipment (e.g., temperature and pressure) are compatible with the process.
- Checking that the equipment will be installed in a location that meets the manufacturer’s guidelines (for example, allowing enough air flow around the equipment, or making sure it is away from damaging environmental conditions and vibrations).
- Confirming that any software is properly installed, and that the hardware meets minimum system requirements.
Often, some form of qualification testing is done by the equipment manufacturer prior to shipment. Reviewing and documenting those tests should be part of IQ, but these tests are generally insufficient to represent a full IQ on their own. In this case, it is the responsibility of the customer to validate proper installation and operation of the equipment.
The second part of IQ is confirming proper installation. In most cases, this involves a thorough review of the manufacturer’s installation guidelines for the equipment and any associated sub-systems. Questions that should be covered include:
- Do the supplied utilities conform to the requirements set by the manufacturer? For a complex piece of manufacturing hardware, this could include things like the power requirements (voltage, phase, and total current needed), cooling water specifications (flowrate, purity, temperature), compressed gas requirements, or any other utility connections.
- Are all material and electrical connections made according to the piping and instrumentation diagram (P&ID)? This should involve a thorough checking of all components on the diagram, including flow directions, indicators, and welds.
- Are pipes properly labeled, and insulated where needed? Are filters in place where needed?
- Where needed, are weld log numbers recorded and welds verified?
- Does the required footprint of the equipment fit within the required space?
- Is all ancillary equipment properly installed and communicating with the main piece of equipment?
- Has any required calibration been performed, and proper documentation of calibration evaluated (either internal or vendor calibration)?
- Are SOPs written that cover operation of the equipment? For example, in cases where equipment is cleaned periodically, is there an SOP for cleaning in place before the first use of the equipment?
Examples of the type of problems that can be uncovered during IQ range from minor setbacks (for example, the supplier sending a pump configured for 220 V power, when a 110 V outlet is available for the pump) to major quality issues, like the wrong type of spray nozzles being installed on a food container sanitation unit.
Any important data or previous records related to the equipment is collected and recorded as part of IQ. Recall that the central theme of any cGMP program is a thorough and complete data record. Examples of the additional information that would be collected includes:
- Supplier ID and manufacturing dates
- Serial numbers
- Internal asset numbers tagged onto equipment
- Calibration records or other pre-testing data from the manufacturer
- Documentation and manuals, including for any computer or software control
- Record of calibration and verification dates for any equipment used for the installation
- Records that verify materials of construction or conformance to other specifications, for example certificates of conformance, materials test certifications, or certificates of analysis
- Spare parts list
- Preventive maintenance (PM) schedule
In this process, Commissioning and Qualification (C&Q) engineers are responsible for familiarizing themselves with the manufacturers guidelines to a level where the guidelines can be understood and followed. They also need to have a deep understanding of the process requirements for the equipment, and the utilities available for equipment connection.
In addition to the primary goal of ensuring product quality and protecting consumer safety, good IQ guidelines also provide a framework to bring new equipment into the plant with minimal unnecessary delays. For example, some of the simple checks discussed here, in addition to ensuring product quality, can also prevent the need for costly reconfiguration of improperly installed equipment later.
Source : DICKSON DATA