Installation Qualification is a documented process that confirms that critical pieces of equipment, piping, software or instruments that directly impact product quality have been;

• Properly delivered (i.e you were shipped exactly what you ordered)
• Correctly installed
• Configured according to standards set by the manufacturer or by an approved installation checklist

Think of it as a process of checking and verifying a piece of installed equipment against a prepared checklist to make absolutely sure it meets the design specifications and has been installed correctly.

For example, if you have just installed a new pressure vessel, you want to make sure that the manufacturer shipped you the right piece of equipment, made from the right materials as per the design specifications, that it is installed in the correct location, and that the pipework, instrumentation or electrical wiring are connected up properly.

This process is carried out by Commissioning, Qualification, Validation (CQV) Commissioning and Qualification (C&Q) or Validation Engineers or Technicians and includes the following activities:

• Verifying that the manufacturer’s technical specifications of the equipment match the design and operational requirements as determined in the facility design element of the qualification process
• Cross-checking of contents against the packing list and checking for damage
• Checking the correct piece of equipment is installed in its proper location
• Verifying (wiring or piping) connections with other units or equipment
• Checking the installation of secondary instruments and ancillary equipment
• Checking for proper energy or utilities supply
• Confirming that the environmental and operating conditions are within the manufacturer’s guidelines
• Verifying software installation
• Recording firmware versions and serial numbers
• Recording calibration and validation dates of equipment used for the qualification
• Gathering all documentation, manuals, calibration certificates and certificates of conformity

This entire process is documented on pre-approved checksheets and signed by the person performing the procedure and then approved and signed by a senior validation peer and quality assurance.

Here are some examples of professional IQ Templates for equipment installation verification, instrument installation verification, piping instrumentation verification and a P&ID walkdown template.

Operational qualification is a documented testing process to make sure that the equipment and systems operate as defined in the design stage and are within the operating ranges listed by the manufacturer.

This is the next step and confirms that the equipment runs the way it’s supposed to run.

To carry this out, C&Q engineers must work with maintenance personnel, process, chemical, automation, instrumentation & mechanical engineers and follow a test plan. They test the equipment, document the performance, then compare and verify against the design specifications.

Features of the equipment which might be tested at this phase of the qualification include:

• Temperature Control Systems
• Overheating/Low-Temp Alarms
• Pressure Control Systems
• Fan/Motor Speed/RPM
• Display Units/Human-Machine Interface Units (HMI’s)
• Operational Signals
• Servo Motors Accuracy
• Pressure Switches
• Level Switches

Tests of these features may involve simple tests such as sending power to the unit and opening/closing different ports and valves to ensure signals or switches and ensure that the components are in working order.

Other more complicated testing may need to be carried out such as the following:

• Pressure Test
• Flow Test
• Testing of Equipment Interlocks
• Speed Test

Performance Qualification confirms that the equipment and systems meet the users’ needs and is fit for intended use as defined in the user requirements specification (URS). It is the final step in equipment qualification. 

It is much like Operational Qualification, as it tests the operational requirements of the equipment, but in this case, the equipment will contain a load or process medium.

In other words, you test the equipment while it’s being subject to “real-world” conditions – conditions which the equipment would be subject to during batch production.

This phase is hugely important as it combines the workings, forces and energy of the individual components of the equipment into one harmonious system. By doing so, faults such as the examples below (as well as many more) can be discovered in this phase of qualification:

• Excessive Vibration/Noise – This may be caused by a combination of 2 or more individual vibrating components leading to resonance.
• Excessive Heat – This may be caused by a build-up of heat due to a driving belt.
• Process Media Backflow – This may be caused by incorrect sizing of pipework (a factor that is only highlighted in this case).
• Pressure Differentials – This may be caused by the use of a valve (toggle open/closed) or other equipment, as well as process media backflow, as mentioned above.
• Combination of Individual Faults – Problems in the system can also arise due to a combination of these faults.

Performance Qualification must not be confused with Process Validation (PV) (or qualification that is the verification that good product is made) or with validated cleaning and analytical methods.

The  V-model is a method used to visualize and compare the relationship between the user requirements, functional design and detailed design to the installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) performed on them (see diagram below).

You start at the top left with user requirements and then back to the top right, ending at PQ.  The left-hand side of the V represents what the system does along with how the system works. The right-hand side of the V represents how you test the system to confirm that the system is fit-for-purpose, i.e. will make safe medicines for patients.

In pharmaceutical manufacturing, most companies and organisations follow the  ISPE’s V-Model (ISPE Baseline Guide Volume-5) to validate their systems as it meets the requirements of the industry regulators such as the Food and Drug Administration (FDA) or the European Medicines Association (EMA).

An Equipment Qualification Protocol is a written plan stating how the qualification process will be conducted. It includes a component-level impact assessment, the steps to perform IQ OQ and PQ, test parameters, product characteristics, production equipment and decision points on what constitutes an acceptable result.

Think of a qualification protocol as a highly detailed checklist with 2 steps:

Step 1: This is where you write and develop the protocol – think of this as preparing a highly detailed checklist which details factors like:

• Impact assessments – you don’t want to validate and test everything as that would be hugely expensive and wasteful. So first you conduct a component-level impact assessment on the system to figure out what components are critical and directly impact product quality vs those items which are non-critical and don’t and only validate the items that are critical.
• IQ OQ PQ test checksheets – e.g. equipment installation, instrumentation installation, piping installation, P&ID walkdown installation checksheets to document and record results
• Test scripts and methods – telling you the steps involved in conducting a test
• Test parameters and acceptance criteria – defining acceptable test results
• Product characteristics – showing what your system is looking to achieve/produce
• Production equipment – detailing the equipment necessary
• Final approval – documenting that the validation process has been successfully carried out

Step 2: This is where you take the document out on-site and execute each of the IQ OQ or PQ protocols – think of this as leaving your desk and going out on-site. And then with the checklist in hand, using it to test and confirm everything is installed and works as intended under load.

Always Remember!

1. The goal is to make safe medicines at an affordable cost and you must balance these objectives. There can be a tendency, especially amongst novice C&Q technicians and engineers to qualify all components in a system. However, the qualification process is enormously time-consuming and expensive and consequently, this approach drives the cost of qualifying and validating the project and subsequently the final price of medicine way higher than necessary (which makes it unaffordable to the less well-off). The solution is to use impact assessments and risk management tools in a scientifically robust manner to support your decisions about what to validate and avoid over-qualifying.
2. There is no such thing as only one right answer or the perfect approach to validate a project. In fact, there are multiple right answers and approaches. The key point is that you must be able to explain your rationale to an FDA or EMA auditor or supervisor. As long as your rationale is sound and logical and even if someone disagrees with you, they understand the decision and you won’t be penalised (even if you are asked to change it).

Documentation Required to Write the IQ Protocol

1. Validation Master Plan (VMP)
2. User Requirements Brief and Requirement Specification c) Supplier’s Drawings and Specifications, including:
   1. Purchase Orders and Contracts
   2. Manufacturer’s Data Sheets
   3. Process Description
   4. P&IDs
   5. Equipment List
   6. System Hardware / Software Specifications
   7. Instrument List
   8. Documentation Required to Execute the IQ Protocol
      

The following is a list of documents that are typically required to execute an IQ protocol:

• P&IDs and drawings
• Instrument List
• Equipment List
• Material Certifications
• Spare Parts List
• Change Parts List
• Installation Check Sheets
• Lubricants Schedule
• Calibration Check if done during the IQ phase

Documentation Required to Write the OQ Protocol

1. P&IDs
2. Functional Requirement Specification
3. Equipment operations manuals
4. Standard operating procedures
5. Supplier Drawings and Specifications including:

• • Process Description
  • Equipment list
  • Instrument List
  • Alarm/Interlock schedule
  • Control system operation manuals
  • References for local, national, and international codes and standards

Documentation Required to Execute the OQ Protocol.

The following is a list of documents that are typically required to execute an OQ protocol:

• P&IDs
• Instrument List
• Equipment List
• Calibration Check, if done during the OQ phase
• SOPs (Operational)
• Approved IQ Protocol

Documentation Required to Write the PQ Protocol

The following is a list of documentation that is typically required to write a PQ protocol:

• Piping and Instrumentation Diagrams: The PQ should reference specific sampling points, instrumentation, and equipment as indicated on the P&ID.
• User Requirement documents: The system owner specification should be used in developing acceptance criteria for the PQ document. Note that this may be different from the design specification and the equipment supplier specification. The owner requirements may be less stringent than the design specification. The goal of the PQ is to ensure that user requirements are met, and not to qualify the design.
• Pertinent regulations, guidelines, and owner specifications.
• System Acceptance Criteria: System acceptance criteria must be clearly indicated in the PQ document. If available, the user requirement specification for the system should provide this information. Depending on the system, acceptance criteria may be contained in the following documentation (This list is not all-inclusive, but given to provide an indication of typical references for acceptance criteria):
  
  • HVAC Systems: Zoning Diagrams, (showing area classifications, room pressurizations), Industry Standards. Additionally, many firms have internal specifications based on process needs.
    
  • Pharmaceutical Grade Water Systems: Acceptance criteria for standard grades of water such as WFI and Purified Water are given in the U.S. Pharmacopoeia (USP) and other industry references. Additionally, many firms have grades of water, which are unique to their process needs. Acceptance criteria for these would be given in company specifications.
    
  • Clean Compressed Gases (product contact): Broad acceptance criteria are included in the USP. Most firms have internal specifications for acceptance criteria for product contact gases.
  • SOPs: The PO document will reference specific SOPs to ensure that the system is operating consistently, samples are taken correctly, and analytical procedures are followed. SOPs should not be repeated in the protocol document; however, SOPs must be available to reference.

Documentation Required to Execute the PQ Protocol

The following is a list of documents typically required to execute a PQ protocol:

• P&IDs
• Approved SOPs for system operation
• Approved SOPs for the operation of test equipment
• Approved Sampling SOPs
• Approved Analytical SOPs
• Load Configuration Diagrams (for autoclaves, washers, etc.)
• Method in place for analysis of all samples
• Calibration Certificates (for process instrumentation and test instrumentation used in executing the PQ)